Common Form: Interagency Domestic Manufacturing Waiver Form

INTERAGENCY DOMESTIC MANUFACTURING WAIVER REQUEST FORM
NOTE: Agencies may follow up with supplementary questions, requests for clarification,
or requirements for additional information. Attach additional pages where needed to provide additional information.

CONTROLLED UNCLASSIFIED INFORMATION NOTICE: This document may contain Controlled Unclassified Information,
trade secrets, commercial, or financial information obtained from a non-governmental source. Such information may be
protected by law or regulation from unauthorized disclosure.
OMB REPORTING BURDEN: OMB Control Number: ####-#### Expiration Date: __/__/____
A Federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to
a penalty for failure to comply with an information collection subject to the requirements of the Paperwork Reduction
Act of 1995 unless the information collection has a currently valid OMB Control Number. The approved OMB Control
Number for this information collection is ####-####. Without this approval, we could not conduct this survey/
information collection. Public reporting for this information collection is estimated to be approximately: 13 hours,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed,
and completing and reviewing the information collection. Send comments regarding this burden estimate or any other
aspect of this information collection, including suggestions for reducing this burden to National Institute of Standards and
Technology, Technology Partnership Office at: 100 Bureau Drive, Gaithersburg, MD 20899, Attn: iEdison Administrator,
[email protected].

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CONTACT INFORMATION
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Contractor/Petitioner Organization
Contractor/Petitioner Organization
Address
Contractor/Petitioner Point of Contact
a. Name
b. Email Address
c. Phone Number
Primary Contact (if different from above)
or Additional Point of Contact (optional)1
a. Name
b. Email Address
c. Phone Number
d. Name of the Party the Additional
Contact Represents

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SUBJECT INVENTION DETAILS
Repeat this section for each subject invention involved. Attach additional pages as needed.
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Invention Report Number(s)
Primary Funding Agency
Other Funding Agency(ies)
Agreement Number(s)
Invention Title(s)
Invention Docket Number(s)
Patent Docket Number(s)
Patent Applications and Patent Numbers
included in request

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LICENSE & LICENSEE INFORMATION (if applicable)
Licensee information provided may be of existing licensee(s) or prospective licensee(s)
13. Name of Licensee or Proposed Licensee
14. Names of any Sub-Licensees
15. Business Address of Licensee (optional)

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Additional Point of Contacts may be a secondary person at the Contractor Organization, an attorney, the Licensee, or other
representative. Adding an Alternative Point of Contact allows the agency to also correspond with this individual regarding this
request.

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16. Exclusive or Non-Exclusive License
17. Fields of use to which the license is or
could be restricted
18. What is the scope of rights given (e.g.,
U.S. versus worldwide use and sales)?

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TECHNOLOGY AND PRODUCT
19. Describe the technology, including products to be manufactured or specific processes implementing the subject
invention.

20. Describe the current stage of development of the subject invention and any development milestone plans
necessary for manufacturing and commercialization.

MANUFACTURING INFORMATION
21. What are the manufacturing plans for the subject invention. Describe any hurdles (manufacturing or otherwise)
to be overcome to make the technology practical as well as the projected manufacturing start date.

22. Discuss the factors that make domestic manufacture not commercially feasible, including:
a. Implications of substantially manufacturing in the U.S. on commercial adoption risks, including those related
to the value proposition for the technology to meet the market demand, market acceptance and risks posed
by existing players in the global competitive landscape, resource maturity and the domestic and global
inputs needed to produce the technology, and societal, non-economic risks that may hinder deployment:

b. The relative costs of U.S. and foreign manufacturing:

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c. Manufacturing capabilities within the U.S.:

d. The efforts made to locate, develop, or contract for such manufacturing capabilities, including any previous
efforts to manufacture the subject invention(s) in the U.S.:

e. Approximately how much additional time, funding, and/or other factors that would be necessary in order to
make U.S. manufacturing commercially feasible:

f.

Any other circumstances that make foreign manufacture necessary:

23. Identify any companies, including contract companies, that would be manufacturing the subject invention(s) (if
other than the Contractor/Petitioner, Licensee, or a subsidiary of either one). Do any of those companies,
including contract companies, have manufacturing locations within the U.S.?

24. Has the Hollings Manufacturing Extension Partnership (MEP) or similar organizations been consulted to identify
domestic manufacturers for the product?
☐ YES

☐ NO

If so, provide any information or documentation provided by MEP or similar organization regarding the
availability of a U.S. manufacturer.

25. Is there any product embodying the subject invention or produced through the use of the subject invention
manufactured in the U.S., or alternatively, is there any U.S. content used in manufacturing the product(s)?
Please describe the scale of U.S. manufacturing (i.e., quantities of U.S. product(s) or content).

26. Where would the proposed manufacturing facility be located (city and country)?

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27. If the location(s) of current or proposed manufacturing facility(ies) is/are not in an allied or partner country
(e.g., Canada, Mexico, South Korea, Japan, the UK, EU countries, those with a free trade agreement as identified
by the U.S. Trade Representative (USTR) in official USTR publications or public announcements such as on Free
Trade Agreements | United States Trade Representative (ustr.gov)), has there been any effort to locate
manufacturing facilities in such jurisdictions? If yes, please provide details of such efforts.

28. Is the proposed manufacturing facility new or an existing facility?

29. For any step in the manufacturing process that would occur outside of the United States, describe the
conditions under which the subject invention will be manufactured abroad (including unionization of
workplaces, health and safety standards, labor and wage laws, and environmental impacts).

30. What is the mechanism(s) by which the company manufacturing the product will acquire the necessary rights to
the subject invention to manufacture the products (e.g., license, exclusive license, assignment)?

31. How will the know-how to manufacture be transferred (e.g., Licensee’s employee or other knowledge being
provided)?

32. How will the Contractor/Petitioner monitor and oversee compliance with the terms of a waiver, if approved,
including the manufacturing and distribution of the products? Please specify the legal mechanism(s) used by the
Contractor/Petitioner and/or Licensee to enforce (e.g., license, exclusive license, assignment) in your response.

PREVIOUS MARKETING EFFORTS
33. Describe all reasonable but unsuccessful efforts made to grant licenses on similar terms to potential licensees
that would be likely to manufacture substantially in the United States. This may include past marketing
strategies and efforts for the technology, including the number of companies contacted, the methods used for
marketing and contacting companies, the types of licenses and terms offered to potential licensees, comparison
of terms offered to potential foreign licensee and those offered to U.S. companies, and the responses of
companies to marketing efforts.

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MARKET AND IMPACT INFORMATION
34. Describe the market size and geographic distribution potential of the technology.

35. Discuss the significance of the technology, including the availability of alternative products, the size of intended
patient populations (if applicable), whether requiring U.S. manufacture will delay entry of the product into the
U.S. market, and the effect any such delay may have on U.S. public health.

36. Identify any value or benefit to the United States of the technology even if it would not be manufactured in the
United States, including I) the direct or indirect investment in U.S. plants or equipment, such as for marketing or
packaging; ii) the creation of new or higher quality U.S.-based jobs, iii) the enhancement of the domestic skills
base, iv) the further domestic development of the technology, v) a positive impact on the U.S. trade balance
considering product and service exports as well as foreign licensing royalties and receipts, or vi) cross-licensing,
sublicensing, and reassignment provisions in the license which seek to maximize benefits to the U.S.

OTHER CONSIDERATIONS
37. To the extent known to the Contractor/Petitioner at the time of the submission of this request, are any
potential economic or national security impacts related to the subject invention or manufacturing the subject
invention abroad? If so, identify those impacts and explain any mitigating factors.

38. Please propose revised U.S. manufacturing requirements. Contractors/Petitioners are encouraged to maintain
the applicable U.S. manufacturing requirements with only such modifications as are necessary to address the
circumstances or concerns which led to this waiver request. Contractors/Petitioners are also encouraged to
include contractual obligations to promote approval by the funding agencies.

39. Please add any additional information or considerations you would like to include with this request. You may
also add any relevant attachments for support. (Optional)

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