word_doc_for_section_3_exhibits_fgk.docx

SECTION 3 – NARRATIVE RESPONSE AND PROPOSED SCOPE OF WORK AND SERVICES

(Spans pages 8‐16 and includes 3 subsections: A,B, and C)

A. MMCAP Infuse Vendor Information and Response Form

i. General Information Company Information

Complete legal name:

Complete mailing address:

Web site address:

Federal Employer Identification Number (FEIN):

Company Contacts

Primary Contact Name

Title

Telephone

E‐mail address

Alternative Contact Name

Title

Telephone

E‐mail address

Administrative Fee Contact Name

Title

Telephone

E‐mail address

Data and Reporting Contact

Title

Telephone

E‐mail address

General Customer Service

Telephone number

E‐mail address

ii. Compliance with minimum qualification. Proposals that have not responded to each Pass/Fail question may not be considered further.

Does Responder comply with each term? Respond Yes or No. Each criterion is Pass/Fail.

Proposals must be received on or before the due date and time specified in this RFP

Responder must have returned a completed Narrative Response and Proposed Scope of Work and Services (Section 3) and completed Exhibits F through K

Authorized Wholesaler/Distributor relationship with at least ten (10) of the listed suppliers in Exhibit F

Responder must demonstrate chargeback capabilities to the MMCAP Infuse contract price with at least eight (8) of the suppliers listed in Exhibit F

Responder must have current and verifiable NABP Drug Distributor Accreditation

Responder must be a licensed Authorized Trading Partner under Title II of the Drug Quality and Security Act, DSCSA

Responder must show proof of being licensed to distribute pharmaceuticals/vaccines in at least five (5) states

B. Scope of Work and Services Any links provided in the narrative response will not be considered. All documents referenced in your response must be submitted with the proposal to be considered.

Experience and Background

1. Will Responder be proposing regional (five or more states) or national (all fifty states) distribution coverage?

a. If proposing regional distribution, provide a complete list of the states serviced.

2. List the addresses of the distribution center locations in Exhibit G. How do the locations of Responder’s distribution centers promote quality and continuity of customer service?

3. From a general overview, describe how Responder will provide for the distribution of routine vaccines, seasonal vaccines, and other vaccines and vaccine‐related products for Members. Include all the distribution services you offer, in detail.

4. Include a summary of information regarding the financial status and current economic conditions of Responder.

5. How long has Responder been in the pharmaceutical and vaccine distribution business? What other products does Responder distribute? What percent of Responder’s current business does vaccine distribution represent?

6. How quickly can vaccine distribution services be provided from the Responder once a fully executed contract is in place?

7. What level of MMCAP Infuse participation will be required in the implementation and ongoing management of a resulting contract? What other assistance does Responder expect to be provided by MMCAP Infuse?

8. What are Responder’s measures of success? Explain any volume or service level targets Responder maintains.

9. Are there any limitations or exclusions Members may be subject to when using your services?

10. What are the names of Responder’s closest competitors and what differentiates Responder from these vendors?

11. Complete and submit three copies of Exhibit K with your response. List names, addresses, telephone numbers, and e‐mail addresses of three references to which Responder has supplied vaccines or vaccine‐related products to in the past three years. Include how these references relate to institutions and corporations of similar scope as Members. One reference must be a government entity. MMCAP Infuse reserves the right to contact any or all references at any point during the evaluation.

Regulatory Requirements

Responder must be able to meet all regulatory requirements to provide vaccine distribution including but not limited to the Federal Drug Administration (FDA), Drug Enforcement Agency (DEA), and all applicable state regulations. Responder must ensure Members will receive the correct vaccines ordered per specifications set forth by the facility and applicable laws.

12. Describe how Responder currently and continuously will comply with FDA, DEA, state, and other national regulations.

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

14. How does Responder maintain an environment for the storage of vaccines that adheres to all regulations and manufacturer specifications?

15. Have you received a citation or warning letter from the FDA in the last 3 years? If yes, include the unredacted information regarding the findings and how Responder remedied the situation.

16. Explain Responder’s DSCSA compliance measures. How is this integrated into your processes? How does Responder provide DSCSA purchasing information to customers? What are your capabilities to export EPCIS data to other data storage vendors?

17. How will Responder ensure and validate that every facility has a GLN as required for DSCSA compliance? What will happen if a facility does not have a GLN? How will Responder address a facility that may have duplicate GLNs?

18. How is DSCSA data securely stored? Is this data storage capacity outsourced, and if yes, who is your outsourced vendor for data storage? Is the DSCSA data stored in the USA?

19. Has Responder ever been found to have distributed fraudulent product? What steps were taken to avoid recurrence?

20. How long does Responder store DSCSA purchasing information for customers? Are there any purchasing requirements from customers for Responder to retrieve their purchasing information for DSCSA compliance purposes? Explain how this data will be readily accessible to Members within the timeframe required by law.

Inventory, Product and Pricing Management

21. Describe how Responder will ensure sufficient stock MMCAP Infuse contract vaccines for Members. What does Responder require from MMCAP Infuse or its Members to ensure sufficient stocking?

22. On average, how many days’ inventory does Responder keep available at each of its distribution centers? How quickly can product be moved from one distribution center to another to meet a Member’s demand? Under what circumstances would product be shipped directly to the Member from a different distribution center?

23. Describe the steps in Responder’s prebooking process for influenza vaccine.

24. What guarantees does a Member receive for prebooking their order? Under what circumstances are prebooked orders cancelled by Responder? What remedies are provided to a Member if a prebooked order is cancelled by Responder?

25. Describe how Responder manages contracts that require a GPO Declaration (DEC) form for Members to be eligible for contract pricing?

26. Describe the chargeback process that Responder has in place with the manufacturers. How will Responder honor MMCAP Infuse contract pricing with Manufacturers?

27. How does the Responder handle contract price loading for multiple tiers of pricing, such as commitment programs whereby manufacturers will specify which Member is eligible for each contracted tier price?

28. MMCAP Infuse will provide a weekly listing of contracted products and pricing. How will Responder use this list to ensure MMCAP Infuse contracted products are stocked and priced correctly?

29. What percentage of vaccine products does Responder receive contracts and pricing electronically from manufacturers via Electronic Data Interchange (EDI)?

30. What are Responder’s current quality controls or auditing processes that ensure MMCAP Infuse contract pricing would be achieved for Members?

31. What is Responder’s process and communication strategy if Responder receives a chargeback denial for a Member?

32. How and when does Responder communicate with Members related to stock outages, backorders, allocations?

33. What would Responder need from MMCAP Infuse to meet the goals of the resulting contract (e.g., resources, Membership listing, etc.)?

Customer Service

34. Describe and demonstrate Responder’s customer service operation for responding to Members’ needs.

35. Where is Responder’s customer service center(s) located? What are the hours of operation? How does this achieve quality customer service for customers in all U.S. time zones?

36. List Responder’s experience and that of the individuals that will be assigned to a resulting contract. How they will interact with MMCAP Infuse and Members utilizing the contract.

37. How does Responder address situations where a customer is a member of more than one GPO or buying group? How does Responder attach that customer to a contract? Does Responder require customers to complete a GPO declaration form? How does Responder ensure that the person signing the form has the legally binding authority to do so?

38. Under what circumstances would Responder encourage or offer to open a second account for a customer for an alternative GPO, buying group, or alternative contract? How would such sales be reported?

39. What is Responder’s procedure for responding to MMCAP Infuse Membership inquiries during non‐operational hours, including holidays?

40. How are Responder’s customer service representatives trained on specific aspects of a GPO contract?

41. Explain Responder’s dispute resolution process.

42. Describe Responder’s customer service operations related to GPOs.

Ordering

43. Enclose as Exhibit H, a copy of all applications, declaration forms, and/or customer account set up information that will be utilized in the creation of Member accounts with Responder.

44. Describe the process of account set up and attaching Members to contracted products for distribution. How will Responder ensure only Members are viewing and receiving MMCAP Infuse contract pricing?

45. Describe Responder’s ability to identify Member accounts that are not attached to MMCAP Infuse contracts or any contracts.

46. Describe how Members will order vaccines. List the methods of placing orders (e.g., email, online orders).

47. Can a view‐only/non‐ordering account be set‐up for staff of MMCAP Infuse? If so, will this account show real‐ time inventory levels? Will it be mirroring a specific Member (with tiered pricing applied) or loaded with base pricing available to all Members?

48. When ordering online, how will Members know a product is on the MMCAP Infuse contract versus a non‐ contracted item?

49. Are there any order minimums?

50. How do customers receive confirmation of their orders?

51. List Responder’s process for emergency orders.

52. Explain Responder’s process for managing expired and short dated product.

Invoicing Members will be invoiced at the more advantageous price between the MMCAP Infuse contract price and the Responder's prices throughout the term of the contract.

53. Will Responder submit an invoice with each order?

54. Enclose a sample of Responder’s invoice as Exhibit I

55. Is this invoice customizable?

56. Will Responder’s invoices contain the following fields? Indicate yes / no in the table below.

Facility Name

Vendor‐assigned account number

Invoice number

MMCAP Infuse Member's purchase order number

Invoice date

NDC (11 digit)

Product Name/Description

Packaging Type

Unit price

Quantity ordered

Quantity shipped

Extension (unit price multiplied by the quantity shipped)

Total invoice price

Bill to address

Ship to address

Shipment All products will be packed in suitable containers for protection in shipment and in accordance with applicable manufacture specifications.

57. Describe processes related to picking correct products and give picking accuracy rate for Responders distribution center(s).

58. Describe all shipping options.

59. Will orders for multiple products be shipped together? Define this process.

60. How will the container with the packing slip be clearly identified?

61. Will all shipping containers have appropriate identification of storage requirements on the outside of the container (e.g., refrigerate upon arrival)?

62. How will lost in mail claims be addressed?

63. What designated carriers does Responder use to ship finished products to facilities? (e.g., USPS, UPS, FedEx, etc.)

64. Explain the custody process and how it is transferred. (e.g., FOB Destination). What insurance is provided standard to all customers via carrier delivery?

Delivery

65. What is Responder’s timeline from order to delivery to the Member? If certain products take longer to obtain than others, please list by individual vaccine.

66. How are deliveries accounted for? (e.g., carrier tracking numbers) Are signatures required for delivery?

67. List sites to which Responder can deliver to (e.g., pharmacy, loading dock, front desk, etc.). How do customers identify their preference to Responder?

Returns

68. Clearly articulate the Responder’s return policy. Does Responder utilize the manufacturer return policy or have more stringent return policies? Explain the impact of DSCSA.

69. How will Members return items to Responder that were sent to the Member in error?

70. How will damaged products delivered to the Members be managed?

71. How quickly can Responder replace damaged product received by the Members?

72. How will credits for returned products be handled?

73. Are credit memos clearly identified as such? Include a sample copy of a credit memo as Exhibit J

74. Describe the processes and methods used for alerting Members in the event of a recall of products. Include timelines, follow up procedure, and other means Responder utilizes for recalls.

75. How will DSCSA impact Responder’s ability to send recall notices to only verified purchasers? Will notices be sent to each ship‐to location for which Responder has a sales history within the affected recall timeframe?

Reports and Data Transfer

76. What reporting elements are available to Members? Are these customizable? How will Members access the reports available to them? In what format (PDF, Excel) are these reports made available? How often are the reports data updated, e.g. real‐time, next day, weekly, etc.? Are the reports available to Members searchable?

77. What reporting elements are available to the MMCAP Infuse at the organization level (as opposed to members)? How can reports be accessed? Can reports be autogenerated and sent to MMCAP Infuse on a scheduled basis? How often are the sales data updated, e.g. real‐time, next day, weekly, monthly, etc.?

78. The reports to MMCAP Infuse will need to be searchable and sorted in various ways. Can this be achieved?

79. Monthly Sales Data Usage Report. Indicate in the last column in the table below whether Responder can submit the requested information to the MMCAP Infuse in a monthly report.

Excel Column Required Data Field Full Name for Sales Data Report

Yes/No

D Vendor-assigned Account Number for MMCAP Infuse Member (this should be the ship-to account number)

I

Buyer name or equivalent of buyer ID for person submitting the invoices (if available)

K NDC of purchased Product as stored in First DataBank, Inc. (Required for pharmaceutical Products)

V

Quantity Shipped (not Vendor repackaged or re-bundled quantity)(99999.9999)

W

Extension (unit price multiplied by the quantity shipped) EXTENDED PRICE (99999.9999)

X Type of transaction 1= MMCAP Infuse Contract Product sale, 2=Alternate Contract, 3=Non- contract Product Sale

AK

MMCAP Infuse Assigned Vendor Code (Codes will be assigned during the implementation period of the contract)

Cybersecurity

80. What has Responder done to address cybersecurity threats and vulnerabilities that may impact your business?

81. Does Responder maintain insurance coverage for cybersecurity/ransomware? At what coverage level?

82. Explain Responder’s use of safeguards such as encryption, antivirus and anti‐malware programs. Describe Responder’s process to contact customers via email or other electronic messaging. Identify whether Responder uses secure email or any procedures to authenticate customer instructions received via email or electronic messaging, to work against the possibility of customer impersonation.

Additional Service Offerings

83. List Additional Service Offerings not identified in this proposal that would benefit Members. MMCAP Infuse is looking to expand the scope of vaccine distribution; optional offers and pricing is encouraged. Pricing for any of these additional products and services must be outlined in the “Cost Proposal Sheet” under Additional Service Offerings Pricing.

C. Alterations or Additions to the State’s RFP Terms & Conditions If you wish to take an exception to the State’s General Requirements (see Exhibit A), please indicate that below and attach any appropriate documentation. Only the template provided here will be accepted.

· None

· See attached document detailing proposed alterations and/or additions to the MMCAP Infuse terms.

EXHIBIT F

MMCAP Infuse Contracted Suppliers Indicate the vendors Responder has current agreements and chargeback systems in place with. Respond directly into the table below and submit a completed Exhibit E with your response.

MMCAP Infuse-contracted vaccine and related product suppliers

Yes

No

Yes

No

Kedrion Biopharma Inc.

Par Pharmaceuticals

MMCAP Infuse -contracted service providers that may interact with resulting contracted Responders

Able to integrate with the following Vendors and systems?

Inmar/ RxTransparent for DSCSA Compliance Services

Inmar Rx for Pharmaceutical Returned Goods Processing Services

PharmaLink for Pharmaceutical Returned Goods Processing Services

EXHIBIT G

PROPOSED DISTRIBUTION CENTERS

Instructions: For the proposed service area(s), include the distribution center(s) that will provide service to Members (the distribution center identified must meet all regulatory requirements to service Members).

In the table below identify the distribution center and the states serviced by the distribution center:

1. National Distribution

2. Regional Distribution

EXHIBIT K

References Sheet Instructions: Complete three (3) Reference Sheets for customers similar in size and scope to MMCAP Infuse, for which services similar in size and scope to those in this RFP were performed in the past three (3) years.

Responder’s Name:

Customer Reference Name:

(Full name of private, non-profit or public sector client)

Customer Reference Information:

Contact Name:

Contact Title:

Mailing Address:

Direct Telephone Number:

Direct Fax Number:

Direct E-mail Address:

Engagement Date(s):

Describe the services provided in sufficient detail to identify size, complexity, your company’s contribution to the success of this customer, and how those results are relevant to this RFP. Include any implementation delays, contracting issues/resolution, and/or any closing relationship issues with the customer. Please be advised that these references will likely be called to validate what is disclosed.