Amendment 2_Questions and Answers.pdf

Solicitation No. 75A50122R00001

Amendment 2 – Questions & Answers

1. Are Non -Disclosure Agreement’s allowed in the process?

NDAs: Yes, if you require NDAs, we can arrange for those to be signed by our contractors that support the proposal evaluation process. Note however that all of our contractors already have signed NDAs with their parent companies to NOT divulge protected information. Also, ALL of the U.S. Government personnel and contractors are bound by FAR 3.104, which describes the protections and efforts necessary to ensure procurement integrity of your protected information.

2. What products are sterile?

What sterilization method is preferred (Ethylene Oxide, Gamma) Cleanroom classification requirement (Class 8 for example)

Regarding sterility, we do not have a particular preference. Whatever sterilization methods you already have in place with the vaccine manufacturers will be acceptable to the Government.

3. Would you provide more detail on the product? (Reference chart Attachment 1, page 3)

Photographs Sample product Component/assembly specifications Bills Of Materials Work instructions Packaging specifications Any current supplier information, if available

Regarding specific products details, this again depends on the specific single use tubing assemblies, pumps, mixing systems and sterile packaged components you are currently providing to the vaccine manufacturers.

4. Is there target pricing for the aforementioned products listed (Reference chart Attachment 1, page 3)?

Regarding target pricing, the Government is seeking, in consideration for our investment, pricing that is no higher than your lowest commercial pricing (i.e. we are seeking your lowest commercial price).

5. Do the products to be manufactured fall under the “Pharma” category?

Does the program involve Active Pharmaceutical Ingredients (API’s)?

If so, what class?

For this solicitation, we are only seeking the consumables products identified in the RFP and identified in item 3 above, and which are already part of an FDA approved COVID-19 vaccine manufacturing process.

6. “Mixing system”, what does this refer to, more detail would be helpful?

Solicitation No. 75A50122R00001

The Government does not have a performance specification for “Mixing System”. This term is a standard industry term for a variety of single use disposable products for vaccine product mixing, and specific performance specs are proprietary to the individual manufacturers.

7. Is there aseptic filling involved with this project?

Regarding “Aseptic Filling”, this is NOT a requirement of this project. This RFP seeks companies that manufacture consumable products that support the COVID-19 vaccine manufacturing process.

8. Would you provide product service codes?

The Product Service Code for the contract is Z2EC.

9. How many examples of ‘Past Performance’ are you looking for and in which Volume should they be submitted?

There is no limit to the examples of past performance, although 1-4 is a reasonable number. Examples should be relevant to prior contracts providing required items with COVID- 19 vaccine manufacturers.