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Submitting a Domestic Manufacturing Waiver Request

Submitting a Domestic Manufacturing Waiver Request

Things to Know Before Submitting a Domestic Manufacturing Waiver

The Bayh-Dole Act requires that if a contractor grants the exclusive right to make or sell any subject invention in the United States, any products "embodying the subject invention or produced through use the subject invention" must be "manufactured substantially in the United States." Additionally, some funding agreements may extend these manufacturing obligations to include products produced by the contractor themselves, non-exclusive licenses, and/or licenses outside of the United States. However, in certain circumstances, this requirement may be waived by the funding agency (see the Bayh-Dole regulations for additional information). If you are seeking to have this manufacturing requirement waived, you must submit a Domestic Manufacturing Waiver Request.  

NOTE: A supporting document is required to submit this request AND you must indicate the reason for your request. Ask your funding agency for the documentation they require for Domestic Manufacturing Waivers. The funding agency may ask for additional information in reviewing this request and may limit your Domestic Manufacturing Waiver to specific time frames, fields of use, countries, etc.

To submit a Domestic Manufacturing Waiver Request, complete the following steps:

  1. Click the "Add Request" button on an Invention Report
  2. Select "Domestic Manufacture Waiver" and enter the required information
  3. Click "Save"

1. Click the "Add Request" button on an Invention Report

Under the Requests section of an Invention Report, click the "Add Request" button.

Waiver request screenshot.

2. Select "Domestic Manufacture Waiver" and enter the required information

After clicking the "Add Request" button, a popup window will open requiring you to select the request type.

Waiver request screenshot.

Select "Domestic Manufacture Waiver" from the pulldown menu.

Click the "Support Document" to upload a required support document.

Choose the reason for the request from the "Domestic Waiver Reason" pulldown menu. The options include:

  • Reasonable but unsuccessful efforts to license to company with U.S. manufacturing
  • Domestic manufacturing is not commercially feasible
  • Both

3. Click "Save"

Click the "Save" button on the popup window.

Administrators at the primary funding agency will be notified of the Domestic Manufacturing Waiver Request. If approved, you will receive a notification indicating the approval. The decision and decision date will be displayed next to the request in the Invention Report. Additionally, the agency may include an official waiver approval document as an attachment to the request, which will include the terms and conditions of the waiver approval.

If the request is denied, you will receive a notification indicating the denial. The decision, reason(s) for the denial, and decision date will be displayed next to the request in the Invention Report.

Created May 25, 2022, Updated July 1, 2022