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 Is the cargo arriving on wood or plastic pallets? Could be a mix Is the cargo arriving with temp monitors? If so, do we need to download data? Proper cold chain procedures must be followed in accordance with manufacturers specifications. Cold chain data will need to be provided to the Government.

Any possibility to get the volume ramp up? In the event of a response there could be added volume How fast does the inventory turn? Depends on the response and demand Approx pallets per inbound? 26 single stack per truck What’s the percentage of case pick? Eaches? TBD depending on scale of response and minimum order quantities With regards to the temperature controls, how much time can material be outside of temp control before it is an issue (unloading and loading from cooler)? Cold chain products must maintain a temperature between 2-8 Celsius at all times.

Would we need to obtain Drug Distribution Accreditation or its state equivalent for each state that we are servicing? Yes

Can we run a fixed variable cost to cover transportation? Contractors should propose in accordance with the tables provided in the solicitation by zone Is the 2800 pallet total per location or just a flat total of 2800? 2800 total Can we submit the transportation and disposal portions of the SOW as cost plus? No, we need a cost per pound inclusive of transportation for hazmat and for non-hazmat Who is paying for packaging during the order fulfillment? Packaging is included in the pick pack CLIN price and needs to be a factor in providing a price per package Are we distributing full pallet loads or is it “pick and pack”? Could be either depending on where it's going and for what.

Can you also please confirm how many cases will be in each pallet? Depends on the product but the average number of cases for existing pallets is currently 60 cases

We noticed that all the drugs/therapeutics mentioned in the SOW are not currently authorized for use in the US. Can you provide more clarification on the drugs’ use and shipping expectations? Does this mean that they will be distributed overseas or for another non-commercial USA use? Is it less likely that these drugs are shipped and more likely that they’ll be discarded at the end of the 12 month contract? Materials will be maintained through their expiry and then upon approval will be scheduled for destruction. Drug efficacy is consistently tested against new strains and could be reauthorized by FDA under the right conditions. There is no expectation of distribution overseas other than support to US states and territories.

How many SKUs on hand for ambient and cold chain? The Vendor shall provide VMI for 500 fixed ambient pallet spaces. Additionally, with 30 days of notice the Vendor shall provide VMI for up to 1500 additional pallets of ambient storage space. The Vendor shall provide VMI (logistical and supply chain support) for 400 fixed pallet spaces for cold-chain product 2°C to 8°C. Additionally, with 30 days of notice the Vendor shall provide VMI for up to 400 additional cold-chain pallet spaces for surge capacity.

What is the average number of cases / pallet and units / case? Units vary too much to provide a response but pallet/case is answered in first bullet.

What is the average weight of a parcel package? What is the average dimension? Sizes and weight for each product vary, however pick & pack in this statement of work refers to an equivalent of one Minimum Order Quantity (MOQ) that on average is between 6 and 20 treatment courses.

Are the pallets all 40" x 48" pallets? Pallets are standard commercial sizes for shipping, estimated 26 per truck/trailer load.

Are there product numbers available? The product type and quantity are not relevant to the requirement for pallet space and other requirements in this solicitation.