TxLTS RFI Q_A.docx

When does the facility (or facilities) need to be ready to receive product?

-- Facilities need to be ready to receive product within 15 days of award.

What must be true for product to be considered segregated?

-- USG product must be physically separated/not comingled from all other products, regardless if the facility also is storing the same therapeutic or vaccine for another purpose. LOTS must be segregated.

Is a vault required? Is a cage required? If the answer is yes to either question, what is the breakdown in percentages between baseline and potential pallets that would need to be stored in (a) cage (b) vault (c) "basic" storage?

-- Storage must be in accordance with all federal, state and local requirements for storage and handling of pharmaceutical drugs, including Schedule 2 Controlled Substances. The vendor must be DEA certified to handle, store and distribute controlled substances.

Can you clarify the locations? Up to two locations but distributed from three locations?

-- Vendor may have up to three warehouse locations with distribution capabilities. The intent is to be able to support nationwide distribution in the timeline established in the SOW. One location that can support national distribution that meets the timelines in the SOW is also acceptable.

Approximate and maximum value per pallet for insurance purposes?

-- Historically under the current VMI and depending on product type pallet values range from $3.6M to $12.6M per pallet.

Is a validated WMS required?

-- An active and established WMS system is required to be in place upon award, inclusive of all requisite capability, training and operation to begin receiving product within 15 days of award. Validation is not required before award, however failure to have these requirements met upon accepting award may be considered a breach of contract and subject to termination for cause.

As product is distributed and/or destroyed, does the storage capacity requirement decrease?

-- The cold and ambient storage is fixed with a surge option for both. Cold storage is fixed at 400 pallet spaces for one year and ambient is 500 pallet spaces for one year.

Once the inventory is depleted for the up to 2,000 pallets, is there a plan for replenishment? Or, should we be understanding this as a more temporary contract and H-CORE need?

This is a 12-month contract for 400 fixed cold pallet spaces and 500 fixed ambient pallet spaces, with the ability to surge to 2,800 pallet spaces if there is a need.

Over what time period do you expect the inventory to be depleted?

Inventory will be distributed as required based on the current needs of H-CORE for the period of performance of the contract. Additionally, as products reach their expiration they will be removed from inventory.

Is all inventory, including ambient inventory, required to be stored in a facility with a Drug Distribution Accreditation?

Yes