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NIH Procedures for Requests for Waivers of the U.S. Manufacturing Requirement in Licenses to Extramural Inventions

The NIH has authority to waive the preference for United States industry requirement when a contractor assigns or licenses a contractor owned invention (35 U.S.C. 204). Extramural institutions may request such a waiver on behalf of its licensees. NIH complies with 35 U.S.C. 204 in making determinations regarding the grant of a waiver of the U.S. manufacturing requirement. Section 204 states:

Notwithstanding any other provision of this chapter, no small business or firm or nonprofit organization which receives title to any subject invention and no assignee of any such small business firm or nonprofit organization shall grant to any person the exclusive right to use or sell any subject invention in the United States unless such person agrees that any products embodying the subject invention or produced through the use of such invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the Federal agency under whose funding agreement the invention was made upon a showing by the small business firm, nonprofit organization, or assignee that reasonable but unsucessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

The approval process requires that grantee organizations and contractors provide information and justification for the request as outlined below. In addition to addressing the questions, any other information which the contractor believes pertinent to why the assignment is necessary and in the public interest may be submitted.

After filling out the form, press "Submit" to automatically e-mail the request to the NIH for disposition. Please note that the review by NIH that can lead to the approval of U.S. Manufacturing waiver request will not commence until the answers to the questions and all pertinent information has been received by the NIH. Should you have further questions, please direct inquiries to Edison@nih.gov

To initiate a request for U.S. Manufacturing Waiver, fill out the fields below, then choose "Submit" to send your request to the NIH. All fields marked with an asterisk (*) are required.

Help     U.S. Manufacturing Waiver Request Form
Prefix (e.g. Dr., Ms., Rev.)
* First Name
Middle Name
* Last Name
Suffix (e.g. Jr., Nobel)
* E-mail Address
* Invention Report Number (###9999999-99-9999)
* Grantee/Contractor Organization
* Grant/Contract Number
* Invention Title
* Invention Docket Number
* Patent Docket Number
Help     Reasonable but Unsucessful Efforts to License
* Discuss the significance of the technology, including the availability of alternative products, the size of intended patient populations, whether requiring U.S. manufacture will delay entry of the product into the U.S. or foreign markets, and the effect such delay may have on the U.S. and foreign public health.
* Identify the past marketing strategy 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.
Help     Not Commercially Feasible
* Discuss the factors that make domestic manufacture not commercially feasible, including the relative costs of U.S. and foreign manufacturing, the licensee's manufacturing capabilities within the U.S. and the efforts made by to locate, develop, or contract for such manufacturing capabilities, and any other circumstances that make foreign manufacture necessary.
* Identify the part or percentage of products arising from the invention that would be manufactured outside the U.S.
* Identify any value or benefit to the United States of licensing the technology even if it will 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.
  

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