Bid Amendment 2 12423.docx

PHILIP D. MURPHY

Governor State of New Jersey

DEPARTMENT OF THE TREASURY

DIVISION OF PURCHASE AND PROPERTY

PROCUREMENT BUREAU

33 WEST STATE STREET

P. O. BOX 230

TRENTON, NEW JERSEY 08625-0230

ELIZABETH MAHER MUOIO

State Treasurer

SHEILA Y. OLIVER

Lt. Governor

AMY F. DAVIS

Acting Director https://www.njstart.gov

January 24, 2023

To: All Interested Bidders

Re: Bid Solicitation # 22DPP00737 T1057- WIC Infant Formula Rebate: DOH Revised Quote Submission Due Date: February 8, 2023 (2:00 p.m. Eastern Time) Bid Amendment #2

The following constitutes Bid Amendment #2 to the above referenced Bid Solicitation:

· This Bid Amendment includes answers to questions;

· A Mandatory Pre-Quote Conference was held on December 14, 2022, in accordance with Bid Solicitation Section 2.5, Mandatory Pre-Quote Conference. The following firms were identified as attendees for the Mandatory Pre-Quote Conference:

· Abbott Laboratories Inc; and

· Mead Johnson & Company LLC.

· Please note that for all additions, deletions, clarifications and modifications to the Bid Solicitation, please refer to the Revised Bid Solicitation titled “T1057 REVISED Bid Solicitation”;

· Please note that all additions, deletions and clarifications to Bid Solicitation Attachment #3, WIC Program Overview, please refer to the Attachment titled, “REVISED Attachment #3- WIC Program Overview”;

· Please note the addition of Bid Solicitation Attachment #7, Invoices for September 2022 through December 2022 titled, “Attachment #7- Invoices for September 2022 through December 2022”;

· Please note the addition of Bid Solicitation Attachment #8, Data file for Issuance of Formula from June 2022 to November 2022 titled, “Attachment #8- Data File for Issuance of Formula from June 2022 to November 2022”;

· Please note the addition of Bid Solicitation Attachment #9, NJ WIC Minimum Stock Requirements effective January 2023 titled “Attachment #9- NJ WIC Minimum Stock Requirements Effective January 2023”; and

· Please note that the Division’s website has been updated. If you are unable to access a web address link directly from the Bid Solicitation, please refer to the following web address links:

· NJSTART Vendor Support Page/QRGs: https://www.state.nj.us/treasury/purchase/vendor.shtml

· Division of Purchase and Property Main Page: https://www.state.nj.us/treasury/purchase/

· Division of Purchase and Property Forms Page: https://www.state.nj.us/treasury/purchase/forms.shtml

· New Jersey Business Ethics Guide: https://www.state.nj.us/treasury/purchase/ethics.shtml.

It is the sole responsibility of the Bidder to be knowledgeable of all of the additions, deletions, clarifications, and modifications to the Bid Solicitation and/or the New Jersey Standard Terms and Conditions relative to this Bid Solicitation as set forth in all Bid Amendments.

All other instructions, terms, and conditions of the Bid Solicitation shall remain the same.

Bid Solicitation #22DPP00737 Bid Solicitation T1057- WIC Infant Formula Rebate: DOH Answers to Questions

Where applicable, each question references the appropriate Bid Solicitation section.

Section Reference Question (Bolded) and Answer

PDF Documents

When trying to open a Portable Document Format (PDF), I am receiving an error message and am unable to access the PDF. How should I proceed??

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Quote Submission Should I check that I have properly completed and attached all of the required documents with my submitted Quote?

Yes. Prior to the Quote Opening Deadline, a Bidder should review the documents comprising the submitted Quote to ensure that all of the required documents have been completed and attached. Oftentimes a Quote is deemed non-responsive because a Bidder fails to attach a required form or attaches a blank form. To review a submitted a Quote, a Bidder should log into NJSTART and review each document attached to the Quote submission. Instructions on how to review a submitted Quote can be found in the Quick Reference Guide entitled How to Review a Submitted Quote, which is available on the NJSTART Vendor Support Page under Vendor Reference Guides.

Please confirm a Bidder may deliver a hardcopy quote instead of submitting a response electronically.

In light of the dangers posed by the COVID-19 virus outbreak and the declaration by the World Health Organization of a global pandemic and Governor Murphy Executive Orders (https://www.state.nj.us/infobank/eo/056murphy/approved/eo_archive.html), which declared both a Public Health Emergency and State of Emergency, please be advised that all Quotes shall be submitted electronically through NJSTART.

Exceptions

Will the State allow Bidders to take exception to any of the Standard Terms and Conditions?

As stated in Bid Solicitation Section 2.2, Exceptions to the State of NJ Standard Terms and Conditions (SSTC): "Questions regarding the State of New Jersey Standard Terms and Conditions and exceptions to mandatory requirements MUST be posed during the Electronic Question and Answer period and shall contain the Bidder's suggested changes and the reason(s) for the suggested change(s)."

Section 2.1 Electronic Question and Answer Period Acknowledging that future timetables for the bid processes may change, please confirm the State will allow at least ten (10) business days between the day responses to questions are published and the day that bid proposals are due.

Answers to Bidders Questions shall be posted at least ten (10) business days prior to the Quote Opening Due Date.

Electronic Question and Answer Period Are bidders able to reach out directly to a state contact if the answers to questions are not satisfactory?

Bidders may not reach out to the procurement specialist for additional clarifications on questions. Only questions as it relates to NJSTART may be asked to the NJSTART Administration Team at: NJSTART@treas.nj.gov.

Electronic Question and Answer Period Are the questions that are posted with the bid for general purposes?

Yes, questions posted with the bid are for general purposes and to assist bidders with issues that may arise with bidding.

Bid Amendments Does the issuance of any amendment need to be signed and included as part of the quote?

Bid Amendments are incorporated into the terms of the Bid Solicitation prior to the submission of Quotes. No signature is required from the bidder.

Section 2.5 Mandatory Pre-Quote Conference Do any questions intended to be addressed in the Pre-Quote Conference meeting need to be submitted in the online bid Q&A form, or can all Pre-Quote applicable questions be answered in the conference call?

The purpose of the Pre-Quote conference is to only address procedural questions regarding the Bid Solicitation and Quote submission requirements. No questions relating to the Scope of Work or the services or products required in the Bid Solicitation will be addressed. Vendors must utilize the Q&A Tab of the Bid Solicitation in NJSTART to submit those questions electronically. All Questions asked during the Pre-Quote Conference shall be posted and answered during Q&A.

Section 3.1

(a) Please advise how the State will comply with Federal Regulations and "publicly open" electronic bid submissions.

(b) Please identify everyone who has access to bids once they have been submitted online, prior to the official bid submission deadline.

(c) Please explain the steps taken to restrict access to bids to those persons identified in response to the question above.

(d) What procedures do you have in place to make sure the online bidding system is functioning properly and accepting bid submissions.

(e) We urge the State to consider allowing bidders to submit an alternate hard copy of their bid in case they have trouble submitting a bid online.

(f) Please explain exactly how much time bidders should plan for e-submissions to be received by the State.

(g) Please provide an email address that will be able to confirm that a manufacturer’s bid has been received by the State.

a) The State shall publically open and read all bids for the first time at the Quote Opening which shall be held at 2:00PM on February 8, 2023. The State shall read all contents required per the Federal Regulations including company name, product brand name, unit size, reconstituted ounces per unit, wholesale price per unit, rebate bid per unit, net cost per unit, percent rebate, and total monthly net cost.

b) No individuals shall have access to bids prior to the official bid opening date.

c) Please see the answer to Question #10b.

d) NJSTART shall be accessible for all Bidders to submit bids for this procurement. It is the Bidder’s responsibility to plan for enough time to submit a Quote in case of a potential error on NJSTART.

e) Please see the answer to Question #3.

f) Bidders are responsible to plan enough time to submit a Quote. The State declines to provide an estimated time as the time varies from company to company.

g) The State declines to provide a specific email address to verify that an individual’s Quote is received. Individuals may email NJSTART@treas.nj.gov if there is an issue with a Quote.

Section 3.1 Quote Submission

a) We encourage the State to provide a video conference of the opening versus a phone conference to assure no bids were opened prior to the bid date and time.

b) We encourage the State to provide an in-person option for the bid opening so all bidders can be assured no bids were opened prior to the bid date and time.

a) The State shall host an in-person bid opening as well as a telephone conference line for those who are unable to attend in person. Please see Revised Bid Solicitation Section 3.1, Quote Submission for further information.

b) Please see Question #11 a.

Section 3.3 Announcement of Quote Information

Please confirm that the following will all be read aloud during the public bid opening: company name, product brand name, unit size, reconstituted ounces per unit, wholesale price per unit, rebate bid per unit, net cost per unit, percent rebate, and total monthly net cost.

The State confirms that the above information shall be read in compliance with the USDA Federal Regulation.

Announcement of Quote Information

This section states all information concerning the quotes submitted may be publicly announced and shall be available for inspection and copying. Please describe the process required to inspect and /or copy proposal information.

The contents of the Quotes shall not be available for inspection and copying until the Notice of Intent to Award is issued by the Director. The Bidders may request a copy of each Quote after the Notice of Intent to Award has been issued.

Please refer to Revised Bid Solicitation Section 3.3, Announcement of the Quote Information, for additional information.

Announcement of Quote Information Please confirm if submissions will be able to be viewed at the end of the opening or after the notice of intent to award.

Please see the answer to Question #13.

Announcement of Quote Information

Please describe the method for ensuring confidentiality for online bids between the bid quote submission and the bid opening. Please also confirm that bid observers will be witnessing the opening of each online quote submission for the first time.

The Bids shall be open for the first time at the in-person quote opening. Bids are unable to be opened prior to the time set by the Quote Opening Date in NJSTART. NJSTART does not allow any individual to have access to the bids prior to the Quote Opening Date.

Please see the answer to Question #12.

Offer and Acceptance Page Is a Certificate of Incumbency required to show that the person signing is an authorized representative of the bidder?

A Certificate of Incumbency is not required to show that the person signing is an authorized representative of the Bidder.

Confidentiality/ Commitment to Defend Is the Pediatric Wholesale Price list to be included with the IFB?

A Pediatric Wholesale Price list does not need to be included as part of the Quote. A wholesale price list is due after award. Please refer to Revised Bid Solicitation Section 4.2, Essential Requirements, for additional information.

Technical Quote Are four (4) references sufficient for the technical quote forms?

The number of references provided with the technical quote forms is up to the Bidder. The Bidder should provide enough information to allow for the State to evaluate the Bidder’s ability to complete the Scope of Work.

Technical Quote Is there a required place to list the company address?

There is no designated place to list the company address. The company address is needed on several forms in order to be considered complete.

Financial Capability of the Bidder Should all applicable financial statements included necessary URLs?

Yes, the financial statements should include all necessary URLs as necessary for a complete financial statement.

State Supplied Price Sheet Instructions As part of its quote, should the price sheet be signed and scanned in or can the document be signed electronically?

The State- Supplied Price Sheet may be signed and scanned in or may be signed electronically. The State shall accept both ways for submitting the signature.

State Supplied Price Sheet Instructions Does the bid sheet require notarization?

No, the State-Supplied Price Sheet does not require notarization.

State Supplied Price Sheet Instructions Is a manufacturer’s price list required?

Please see the answer to Question #18.

Section 4.1 Contract Specific Definitions

Please confirm that full truckload means 44,000-pound pricing as outlined by Federal Regulations and that for the purposes of the submission, pricing that is listed as 44,000 pounds and the definition of truckload are synonymous. If agreed, please add truckload definitions section.

The Federal regulations do not specifically identify the number of pounds in a full truckload. The term “full truckload” commonly refers to the content of a truck in charge of transporting a single kind of shipment in large quantities from one location to another. Although a load of 44,000 or 21.7 tons is commonly referred to as a full truckload in the trucking industry the quantity and weight may vary with product being transported. Since there is no Federal regulation defining the number of pounds in a “full truckload”, this definition will not be added to the definitions section of this RFP.

Section 4.2 Essential Requirements

Please confirm that by submitting a proposal with a signed Signatory Page, the bidder is certifying that they are registered with the Secretary of the United States Health and Human Services in accordance with the Federal Food, Drug, and Cosmetic Act.

Although by signing the Signatory Page, the bidder is indicating that they are registered with the Secretary of the United States Health and Human Services in accordance with the Federal Food, Drug and Cosmetic Act, a signed signatory page, alone is not sufficient proof of certification for this bid solicitation. The Certificate should be included with the bid submission.

Section 4.6 Reformulation/ Product Substitutions/ Changes in Labeling and Packing

a) Will the State be willing to change the notification period from 90 days to 60 days or the same time as other retail customers?

b) Since manufacturers are not making product solely for the State, to have sole right to make final determination of what constitutes an acceptable change, replacement, substitution, or alternative Infant Formula as part of the WIC Program is not practical. Manufacturing a product formulated for and distributed only in the State could dramatically affect a manufacturer’s ability to execute the requirements of this contract. Please remove this section.

c) If not removed, please provide the reasons that the State feels that this provision is in the best interest of the State, WIC infant participants and the contractor.

a) NJ is not willing to change the notification period to 60 days. Since WIC issues three months of benefits to participants, 90 days allows the State ample time to notify participants of changes to their WIC formula and gives them the opportunity to discuss these changes with their physician.

b) The State would deny a reformulation if it failed to meet the minimum requirements set forth by the USDA WIC program. The provision of the 90 calendar days advance written notification prior to implementation of any product substitutions, changes in formulation of Infant Formulas, as well as changes in packaging, unit size, and labeling is in the best interest of all involved as it provides an opportunity for the State and the Contractor to discuss the proposed changes and ensure that they are in accordance with USDA regulations. The State recognizes customary industry practice; however, WIC Services has the responsibility of providing benefits to its Participants and needs to be involved in the decision making process. Although the State maintains that it has the “sole right to make final determination...,” if it will offer the Contractor’s reformulated, replacement, substitution or alternate product, that determination is made by the State in collaboration with the awarded Contractor.

c) Please see the answer to Question #27 b.

Section 4.6.1 Product Substitution

Please revise the first sentence in this section to: In cases where WIC Services must substitute the Contractor’s brands of Contract Brand Infant Formula (milk and soy-based), due to a Contractor’s shortage, supply chain disruption, mandatory or voluntary recall, with another manufacturer’s, the Contractor shall pay Rebates on both Contract Brand and Non-Contract Brand Infant Formula in any available Unit, type, or form authorized by the Food and Drug Administration (FDA) or for which FDA is exercising enforcement discretion in the event of supply chain disruptions determined by the USDA.

The sentence referenced above is the first sentence of Section 4.6.1C. It is not the first sentence of this section (4.6.1) and the first sentence will remain unchanged.

The first sentence in Section 4.6.1 A is specifically referring to substitution of a Contract brand formula that is not available due to the Contractor’s shortage or mandatory or voluntary recall. In these circumstances the State’s preference is, when possible, to substitute a different physical form of the unavailable Contract Brand Infant formula to minimize WIC infants need to change their specific formula they have successful tolerated.

Product Substitution

The Contractor should only be required to pay remedies during the time of the emergency or shortage. Even though typically benefits are issued on a 3 month basis, during an emergency or shortage, it is more prudent to issue benefits on a monthly basis to be able to adjust based on quickly changing circumstances. Therefore, we would request that this provision be changed to reflect that the Contractor is only required to pay remedies during the time of the emergency or shortage even though it may take the additional time for the invoices to be submitted and paid. Please change this section to: The Contractor is only required to pay remedies for benefits redeemed during the time of the emergency or shortage; however, it may take an additional 90 days or 3 calendar months, depending on issuance, after the end of the shortage or emergency as determined by the USDA or State agency, for the invoices to be submitted and paid.

During times when there are contract brand formula shortages, WIC infants are required to switch formula in response to formula availability. Unlike other WIC food items, switching formula on young infants may be challenging and result in several trials before a suitable substitute is successfully tolerated. NJ WIC’s goal is to minimize the impact of Contract Brand formula shortages on our WIC infant population. When the Contract Brand infant formula becomes available in WIC authorized stores, since NJ WIC issues benefits for 3 months the State wants to ensure ample time to notify our infants. WIC clinics do not have the available resources to contact all infants, individually, within the first month of availability of the contract brand formula and it is not appropriate to change a participant’s formula benefits without their knowledge, consultation, and consent.

Note that NJ WIC will begin to issue Contract Brand formula to our new infant applicants, and existing infants that require a change of formula, as soon as NJ is notified of its availability in our WIC authorized stores The State will also immediately change formula benefits to the contract brand formula when requested by a WIC participant in advance of their next benefit issuance.

Therefore, the State reserves the right to request rebates on substitute formulas up to 90 days or 3 calendar months, depending on issuance, after the end of the shortage or emergency as determined by the USDA or State. NJ WIC will maintain this provision in this bid solicitation.

Product Substitution

Please explain in what circumstances this would occur in Section 4.6.1 E. Please confirm in the event of an emergency or waivers from the USDA, the State will adhere to the stipulations found in Section 4.6.1.A-C.

Please see the answer to Question #29.

NJ confirms that in the event of an emergency or waivers from the USDA, NJ will adhere to the stipulations found in Section 4.6.1. A-C.

Product Substitution

What metrics is the State planning to use to trigger the request for USDA waivers? Please explain the circumstances in which this would occur.

The State may seek USDA waivers when a) the Contractor notifies NJ that there is insufficient formula due to a shortage, supply chain disruption or mandatory or voluntary recall, b) NJ WIC authorized vendors or primary WIC distributors indicate a serious and/or prolonged lack of formula deliveries, or c) the Federal Government formally announces a national formula shortage.

USDA waivers are granted only when necessary to minimize hardship to WIC participants. Note that the USDA will only grant waivers when there is sufficient data (at either the national or state level) to support it. Historically, USDA has not issued waivers for short-term and/or sporadic formula shortages.

Product Substitution

Continuing to obligate the contracted manufacturer with rebates on competitive products up to 3 months after the market has recovered is an extreme financial burden and unfair to the contractor, we urge the State to strike this provision.

Please see the answer to Question #29.

Product Substitution

Please confirm that under no circumstances will the manufacturer be required to pay rebates on competitor products unless there is a documented inability to provide Infant Formula in quantities sufficient to meet the demand of the participants.

The State confirms that under no circumstance will the Contractor be required to pay rebates on competitor products unless there is a known inability of the Contractor to provide Contract Brand Infant formula in quantities to meet the demand of NJ WIC participants. Please see the answer to Question #31 for additional information.

Product Substitution

On what basis would the State deny an infant formula that was reformulated? Since manufacturers are not making product solely for the State, to allow the State to have sole right to make final determination of what constitutes an acceptable replacement is not practical. Manufacturing a product formulated for and distributed only in the State could dramatically affect a manufacturer’s ability to execute the requirements of this contract. Please remove this section. If not removed, please provide the reasons that the State feels that this provision is in the best interest of the Department, the State, WIC infant participants and the contractor.

Please see the answer to Question #27 b) and c).

Rebate Payment Scheduling & Submission to WIC Services If the Invoice is disputed by the Contractor, the Contractor shall notify the SCM, in writing, within 90 calendar days from the receipt of the invoice. Invoice disputes will not be considered by WIC Services if the Contractor does not comply with the 90-calendar day dispute period. Will the State please confirm that this stipulation is a reciprocal right for the manufacturer?

The State is confirming that this stipulation is a reciprocal right of the Contractor.

Rebate Payment Scheduling & Submission to WIC Services

a) Also, confirm that the ninety (90) calendar day dispute period does not include disputes which may arise due to fraud or other illegal activities.

b) Confirm that the State will provide vendor redemption data to the Contractor when issues of fraud arise.

c) Please confirm the State will work with the Contractor to provide such data in instances in which rebates have been paid for contracted products based on fraudulent transactions that involve infant formula.

d) Please confirm the State agrees to discuss with the Contractor appropriate means for addressing payment issues identified through manufacturer audits and/or fraud-related issues directly affecting the manufacturer.

e) Please confirm the State will partner with the Contractor on recovery in instances where fraud has been discovered, and it has been further determined the manufacturer was overbilled for infant formula.

f) How many vendors have been disqualified due to fraud issues in the last three years?

g) Please confirm that there is no time limit on disputes arising from fraud or other illegal activity that prevents the Contractor from being able to identify the incorrect billing. If not confirmed, please explain why such a time limit is appropriate.

h) Please explain the State’s processes to identify and curb fraud.

i) Can the State confirm that it conducts compliance buys to ensure that formula is handled correctly at the retail level?

a) The 90-calendar day dispute period shall not apply to disputes which may arise due to fraud or other illegal activities of Participants or WIC Retailers.

b) Confirmed, the State will provide Retailer redemption data to the Contractor when issues of fraud arise.

c) In the event of fraud or other illegal activities involving Participants or WIC Retailers and not involving the Contractor, the State will apply to the USDA for guidance on how to address the situation and would be guided accordingly.

d) Confirmed, the State will discuss with the Contractor the appropriate means for addressing payment issues.

e) Confirmed, the State will take reasonable steps to assist the Contractor in occurrences where it has been determined that the Contractor was overbilled. However, please see the answer to Question #36 (C).

f) In the last 3 years, 2 vendors have been disqualified for fraud.

g) The State declines to provide a response. This is a request for legal advice and should be discussed with the requestor’s legal counsel. Pease refer to Revised Bid Solicitation Section 4.7.2 (C), Rebate Payment, for additional information.

h) The State WIC Vendor Unit conducts vendor compliance buys each year in accordance with USDA regulations. Additionally, the State WIC Vendor Unit performs compliance investigations and formula inventory audits on high-risk vendors. High risk vendors are vendors identified as having high probability of committing a vendor violation through application of the criteria established by federal and state policies.

Inventory audits are conducted on high-risk vendors to determine if the number of cans redeemed by a vendor in the span of three months were supported by the inventory the vendor claimed to have. Vendors must submit copies of their invoices and purchase records and those records are reviewed against the number of cans redeemed by that vendor during the same time period.

The State’s web-based ADP system, WOW, contains functionality that prevents participants from receiving duplicate or over the maximum allowable monthly benefits, unless approved by a WIC clinic professional. Additionally, the State coordinates and shares WIC participation with neighboring States to ensure that individuals are not dually receiving WIC benefits from two or more States during a benefit period. Lastly, the eWIC, real time, point of sale transaction, that requires participants to enter a PIN to access and redeem benefits, prevents participants from purchasing non-authorized foods or exceeding their benefit limit of an item.

i) Confirmed, the State conducts compliance buys in accordance with Federal regulations. At compliance buy involves a minimum of two separate purchases. At least one includes a formula purchase unless the compliance buy is a result of a specific complaint that does not involve formula.

Rebate Payment Scheduling & Submission to WIC Services If the fifteenth of the month falls on a Sunday or a banking holiday, please confirm payment made the following business day will not constitute a late payment or a penalty.

The State confirms that if the 15th of the month falls on either a Sunday or a bank holiday, payment shall be made the following business day. Failure to make a payment by the following business day shall constitute a late payment.

Please refer to Revised Bid Solicitation Section 4.7.2, Rebate Payment Scheduling & Submission to WIC Services, for additional information.

Rebate Payment Scheduling & Submission to WIC Services Please confirm that the contractor is permitted to withhold payment if the overbilling is not supported by the agreed upon invoice documentation to substantiate the invoice balance, and the amount in question significantly exceeds the average of the past 3 months of invoices submitted by the state (variance of greater than 100%).

Per the Federal WIC Policy Memorandum 96-6, the “Contractor must not be allowed to withhold any rebate payments due States under any circumstances.” Based on this Federal requirement, the State cannot permit the Contractor from withholding payment for any reason, including the scenario described above.

Each month, the State will supply the Contractor with detailed data of each Contract Brand infant formula redemption transaction that will directly support the monthly invoice. If the amount of the invoice was significantly above the previous 3 month submissions (i.e variance of 100% or more), the State is required to thoroughly review the data and investigate any discrepancies to ensure the accuracy of the invoice before submission to the Contractor. Additionally the State will provide sufficient documentation (data files), and if necessary, an explanation of the variance, to assure the Contractor that overbilling has not occurred.

b) If not confirmed, please provide a list of data elements that the States will provide on monthly data files and explain how the Contractor can validate that the total number of infant formula cans redeemed by a single participant for the month did not exceed the federally regulated monthly maximums.

a) Confirmed, the data file that will be supplied to the Contractor with the monthly rebate invoice will list the following information for each eWIC transaction: a unique identifier per participant (Participant ID), the family identifier (Family/Household ID), the infant’s birth date, food package/feeding method, eWIC POS transaction number, First Date to Use of Benefit, Last Date to Use of Benefit, date the benefit was issued by the WIC clinic, date redeemed by the participant, number of formula units redeemed, redeemed monetary amount, and formula product description.

Since eWIC food benefits are issued to a WIC family account, it is possible that the WIC household/family may contain multiple participants that receive the same formula (i.e. twins, etc.). In order to identify that the eWIC transaction is for a WIC family that contains two or more members that are issued the same rebate formula for a benefit month, the data file will provide additional information to easily identify these cases. Specifically the rebate data file will list all of the family members’ unique participant IDs, their birthdate and feeding method that are associated with a specific eWIC transaction. Note that in the case of twins/multiples, the birthdate listed in the data file may be the same but each participant will have a unique identifier/Participant ID. This additional information will allow the Contractor to determine the total number participants associated with the total monthly units of formula redeemed by a family unit to ensure that the cans redeemed for each individual family member for a benefit month are within the Federal maximum allowance.

b) Please see the answer to Question #39 a).

The State strives to complete every reprocurement prior to the contract end date. To the extent unforeseen circumstances necessitate a brief transition period between contracts, this section places both parties on notice of their responsibilities and the limited duration of the transition period.

Indemnification In reference to Section 4.1, A.1 of the Standard Terms and Conditions, please remove “or the order” at the end of the sentence. If not removed, please define the “order” as it is used in that sentence.

This phrase has been removed. Please Refer to Revised Bid Solicitation Section 7.1, Indemnification, for additional information.

Indemnification In reference to Section 4.1, H of the Standard Terms and Conditions, “Authorized Purchaser” is capitalized as if it is a defined term, but there is no definition provided. Please remove “Authorized Purchaser” or provide a definition.

“Authorized Purchasers” under this Contract shall mean the Department of Health (DOH), Division of Family Health Services, Woman, Infants, and Children (WIC) Services (WIC Services).

Right to Waive Please confirm the responsive bidder with the lowest total monthly price with be awarded the contract.

Pursuant to Bid Solicitation Section 8.16, the Contract will be awarded to the responsible and responsive Bidder offering the lowest total monthly net price for infant formula as outlined in that Section.

Please see response to Question #43.

Please see response to Question #43.

Clarification of Quote Further, the Director reserves the right to request a bidder to explain, in detail, how the proposal price was determined. Please remove this language from this section as this would be company confidential.

The State declines to modify the language as requested as the Director must have access to whatever information is required to make an award in accordance with all applicable law. Please note that, pursuant to Bid Solicitation Section 3.13.17, Confidentiality/Commitment to Defend, bidders may request that qualifying confidential documents be exempt from public disclosure under OPRA and/or the common law.

Tie Quotes N.J.A.C. 17:12-2.10 provides as follows:

a) In the event that proposals submitted by two or more bidders are tied with respect to price, and the application of the other evaluation criteria specified in the RFP does not provide a basis to distinguish between or among the tied proposals, the Director shall award the contract based on a review of the following factors listed in order of priority: 1. Tie-breaking provision(s) set forth in the RFP 2. A usable cash- or volume-based discount that renders one proposal more favorably priced 3. Delivery advantage, specifically shorter proposed time frames for delivery and/or closer proximity to the point of delivery 4. Active registration on the date of proposal opening as an approved small business with the Department of the Treasury unit responsible for administering the State's small business registration program; and 5. In-State location.

b) When application of the above distinguishing factors does not result in a breaking of the tie status, the Director may, if practicable, make multiple awards. Please confirm that there will not be multiple awards. Please explain how tie bids will be resolved if none of the criteria set forth in this section are applicable.

The State declines to opine on hypothetical facts, and will make a single award in accordance with all applicable laws.

Recommendation for Award

a) Please describe the pre-bid protest procedures and post-proposal due date protest procedures governing this RFP, including relevant time frames for submitting a protest.

b) Please confirm all bidders will be notified if a protest is filed either prior to the bid proposal due date or after issuance of an award recommendation.

c) Please explain when all bids received by the States will be able to be viewed by all bidders.

d) Please confirm all bidders will be notified in the event of a protest on this bid.

e) Please provide details as to when all bids will be published and available via public records request.

Pursuant to N.J.A.C. 17:12-3.2, a written protest to the specifications shall be submitted to the Director only after the Division has formally responded to questions posed during the RFP-established question and answer period and in sufficient time to permit a review of the merits of the protest and to take appropriate action as may be necessary, prior to the scheduled deadline for proposal submission. However, the Director may disregard a protest filed fewer than seven (7) business days before Quote opening.

The Director is not required to provide notice to any other bidders.

As noted in Bid Solicitation Section 3.3, Announcement of Quote Information, the other bidders’ proposals will be available as part of the award file following issuance of the Notice of Intent to Award.

Contract Award Please supply the date when bidders can expect the notifications to be sent for both the notice of intent to award and the contract award. Does the State intend to publish an intent to award? Please provide the exact link to where the Intent to Award will be posted.

The State declines to provide an exact date of when the notice of intent to award shall be sent out or contract award. The Notice of Intent to Award will be mailed to each Bidder.

Contract Award Please confirm all bidders will be notified of the award via email. If not confirmed, please advise how all bidders will be notified of the award.

Please see the answer to Question #49.

Contract Award When does the State anticipate publishing an award?

Please see the answer to Question #49.

Section 3.8 Buy American As the Federal requirements contemplate that the contract award go to the manufacturer who offers the lowest total monthly net cost and do not contemplate that the contract award go to manufacturers with Domestic ties, will the state please strike the provisions regarding the Buy American Preference from the RFP? If not stricken, please explain how this provision aligns with the Federal requirements that govern this bidding process.

The State declines to strike the requested language. Further, the State declines to opine on hypothetical facts, and will make an award in accordance with all applicable laws.

Section 5.7 Termination of Contract Please change the termination for convenience notice period to 6 months as a 30-day conversion will not be easily executed by the new manufacturer. Please confirm that the termination rights are reciprocal to the contractor.

The State declines to accept the requested modification. Please note that no right of termination is granted to contractors under the terms of the Bid Solicitation, and the State does not grant such requested changes as it must have the benefit of the required services that are the subject of the procurement.

Section 5.7 Termination of Contract Please confirm that termination rights are allowed for contractors with one (1) year notification. If not allowed, please describe the reasons why the State is allowed to terminate the contract, but the contractor is not afforded the same rights.

Please see response to Question 53.

Forms Packet Please confirm all the pages of the bid document that needs to be notarized.

There are zero (0) pages of the bid documents that need to be notarized.

Forms Packet Please confirm a completed Bidder’s Checklist does not need to be included in a bid response.

A Bidder’s checklist is not required as part of the bid response.

Forms Packet Please provide a table that includes what is mandatory (1) at time of bid opening, (2) within 7 business days of the state’s request and (3) after opening, but prior to award.

The State declines to provide a table of all mandatory forms. A table for mandatory forms for award can be found on the Bid Solicitation Checklist. All Bidders should refer to the Bid Solicitation for the specific forms that are due at Quote Opening, within seven (7) business days of the State’s Request, and prior to award.

Forms Packet Please confirm a copy of the IFB is not required to be submitted as part of a bid response. Please confirm that issued addenda must be signed and returned with the bid response.

A copy of the IFB is not required as part of the bid response. No amendments must be signed and returned with the Quote.

Forms Packet Please confirm, as mentioned on the pre-bid conference call, that the following documents are the only required documents for bid submission: Ownership Disclosure Form, Disclosure of Prohibited Activities with Russia or Belarus Form, State Price Sheet and the required information to describe plans for accomplishing the work outlined in the Scope of Work. Any of the other documents listed on the checklist or in listed in Section 3.13 of the RFP could be submitted as needed within 7 business days from request of the State. If not confirmed, please be specific as to what forms/documentation would be required for bid submission.

The Ownership Disclosure form is the only form required at Quote opening. However, Bidders should provide all other forms as required by the Bid Solicitation. All other forms shall be requested to the Bidders in order to receive an award. All other forms must be supplied within seven (7) days of the request, or the bidder may be deemed non-responsive. The Bidder must supply in addition a State-Supplied Price Sheet, and a description of its plan to complete the Scope of Work.

Forms Packet This form references section 8.9 in the RFP as the Scope of Work for the contract. However, Section 8.9 in the RFP (page 24) is indicated as the Evaluation Criteria section. Please confirmation the appropriate section that is to be referenced for a bidder to review the Scope of Work for this bid opportunity.

The Scope of Work is Section 4.0 of the Bid Solicitation.

Forms Packet Is the COVID Vaccine from required (EO 271)?

EO 271 was rescinded by EO 302 on August 15, 2022. Thus, the EO 271 Certification is no longer a requirement.

Forms Packet Is the Ownership Disclosure form the only one required by Quote Opening?

The Ownership Disclosure form is the only form required at Quote opening. However, Bidders should provide all other forms as required by the Bid Solicitation. All other forms shall be requested to the Bidders in order to receive an award. All other forms must be supplied within seven (7) days of the request, or the bidder may be deemed non-responsive.

Forms Packet Are the following forms required:

a) Pay to Play;

b) Political Contributions Disclosure;

c) Disclosure of Prohibited Actions with Russia; and

d) Source Disclosure?

All of the above forms are required in order to receive an award for this Bid Solicitation.

WIC Program Overview Please confirm the State will not seek rebates on contracted formulas issued to children.

If Contract Brand formula is issued to and redeemed by WIC participants who are categorized as “children” the State will seek rebates on these units of formula. This is an acceptable expectation since the status of a “child” is given to a WIC participant automatically when they reach their 12-month birth date although the WIC participant may medically require a Contract Brand formula. For example, infants, over 12 months of age, that were born premature, may nutritionally require a Contract Brand infant formula to ensure appropriate growth and development. Since the WIC regulations do not allow an adjustment to the WIC status for premature infants the issuance of Contract Brand infant formula to children is reasonable and medically necessary. Therefore the State will be seeking a rebate for all Contract Brand infant formula issued to infants and children, redeemed at WIC authorized WIC vendors and paid for by WIC funds.

WIC Program Overview Please confirm a manufacturer is not billed rebates for infant formula issued to children.

Please see the answer to Question #64.

WIC Program Overview At the bottom of Page 2, it describes two charts below which demonstrate the number of standard Contract Brand Infant Formula Units. The charts that follow on Page 3 also indicate Standard Contract Brand Infant Formula. It appears that the term Contract Brand Formula has been duplicated for these tables on Page 3 and the original 4 tables on Page 2. Please explain what these tables represent and adjust the language appropriately.

The four tables at the bottom of Page 2 are correctly labeled. However, the two tables that follow on Page 3 are incorrectly labeled. The two tables should be labeled as follows: Standard Non-Contract Brand Infant Formula-Milk Based and Standard Non-Contract Brand Infant Formula-Soy Based. The table titles and the preceding narrative that introduces the two tables in the attachment, have been corrected. Please refer to the Revised Attachment #3 for the corrections.

WIC Program Overview Please include the most recent 6 months of issuance by brand, size, and unit for all contract, exempt, non-contract non-exempt infant formulas The State has attached a data file of the most recent 6 months (June-November 2022) of issuance by brand, size and units for all contract, exempt, non-contract non-exempt infant formulas and nutritionals. Please see Attachment #8 for the data file.

WIC Program Overview Please explain the State’s policy on accepting returned formula from participants. Please confirm that if the State reissues formula (in the event of a return), that the contracted manufacturer will not pay rebates exceeding the federal maximum.

Example: Mom is issued 9 cans of Enfamil Infant powder and redeems all 9 cans. Mom returns 7 cans to the clinic and is issued a new benefit for 7 cans of Enfamil Gentlease powder. Is the State seeking rebates on 9 cans or 16 cans today?

Please explain the State’s policies and accounting for utilizing or destroying returned formula. If above is not confirmed, please detail by age of baby, form, and type how many units of formula are rebated above the federal maximum.

The policy of the NJ WIC Program is to not exceed the issuance of formula above the federal maximum.