| Field
Definitions |
 |
Prefix
(e.g. Dr., Ms., Rev.) |
The prefix to the name of the individual
submitting the waiver request.
|
|
| First
Name |
The first name of the individual submitting
the waiver request.
|
|
| Middle
Name |
The middle name
or initial of the individual submitting the
waiver request. |
|
| Last
Name |
The last name
of the individual submitting the waiver request. |
|
Suffix
(e.g. Jr., Nobel) |
Any suffix to
the name of the individual submitting the waiver
request. |
|
| E-mail
Address |
The e-mail address of the individual submitting
the waiver request. The format for this field
is test@test.com.
|
|
| Invention
Report Number |
The Invention Report number identifies the
invention for which the waiver is requested.
The Invention Report number can contain up to 18 characters. The first 7 characters, before the dash, may vary in length from 4, 5, 6, or 7 values. However, the second half (##-####) must contain values. The complete format for the field is: ##########-##-####.
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|
| Grantee/Contractor
Organization |
The full name of the Grantee or Contractor
Organization that holds the rights to the
invention for which the waiver is requested.
|
|
| Grant/Contract
Number |
The grant or contract number of the primary
agency supporting the invention for which
the waiver is requested.
|
|
| Invention
Title |
The title reflects the title of the invention
for which the waiver is requested. The title
must appear exactly as it appears in the Invention
Report submitted to iEdison.
|
|
| Invention
Docket Number |
The Invention Docket Number field is provided
for the convenience of iEdison users as a
unique identifier to help identify the invention
for which the waiver is requested. The invention
docket number may be any combination of numbers
and letters. If an invention docket number
is not provided, the iEdison system sets the
value equal to the last six digits of the
Invention Report number.
|
|
| 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. |
Briefly summarize the significance of the
technology, especially emphasizing any impact
that the waiver will have on availability
of the product to the U.S. public.
|
|
| 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. |
Explain what steps have been taken to commercialize
the invention for which the waiver is requested.
Explain why efforts to license the invention
to a U.S. company or entity have not met with
success.
|
|
| 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. |
Explain why domestic manufacturing is not
commercially feasible.
|
|
| Identify
the part or percentage of products arising from
the invention that would be manufactured outside
the U.S. |
If the technology involves component manufacturing,
explain what percentage of the final product
will 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. |
Explain how the successful manufacturing
of this product is to the benefit of the U.S.
public.
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