Ti	=	Statutory and {_NIH} Requirements and Reserved Government Rights
1.1.sec	=	{_IC} reserves on behalf of the {_Government} an irrevocable, nonexclusive, nontransferable, royalty free license for the practice of all inventions licensed under the {_Licensed_Patent_Rights} throughout the world by or on behalf of the {_Government} and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the {_Government} is a signatory. Prior to the {_First_Commercial_Sale}, {_Licensee} agrees to provide {_IC} with reasonable quantities of the {_Licensed_Products} or materials made through the {_Licensed_Processes} for {_IC} research use; and
1.2.sec	=	in the event that the {_Licensed_Patent_Rights} are Subject Inventions made under {_CRADA}, {_Licensee} grants to the {_Government}, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid up license to practice the {_Licensed_Patent_Rights} or have the {_Licensed_Patent_Rights} practiced throughout the world by or on behalf of the {_Government}. In the exercise of this license, the {_Government} shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non Federal party. Prior to the {_First_Commercial_Sale}, {_Licensee} agrees to provide {_IC} with reasonable quantities of the {_Licensed_Products} or materials made through the {_Licensed_Processes} for {_IC} research use.
1.	=	[G/Z/ol/s2]
2.sec	=	{_Licensee} agrees that products used or sold in the United States embodying the {_Licensed_Products} or produced through use of the {_Licensed_Processes} shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from {_IC}.
3.sec	=	{_Licensee} acknowledges that {_IC} may enter into future {_CRADA}s under the Federal Technology Transfer Act of 1986 that relate to the subject matter of {_this_Agreement}. {_Licensee} agrees not to unreasonably deny requests for a {_Research_License} from future collaborators with {_IC} when acquiring these rights is necessary in order to make a {_CRADA} project feasible. {_Licensee} may request an opportunity to join as a party to the proposed {_CRADA}.
4.1.sec	=	in addition to the reserved license of Paragraph 5.1, {_IC} reserves the right to grant {_Research_License}s directly or to require {_Licensee} to grant Research Licenses on reasonable terms. The purpose of these {_Research_License}s is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the {_Licensed_Patent_Rights}, however, {_IC} shall consult with {_Licensee} before granting to commercial entities a {_Research_License} or providing to them research samples of materials made through the {_Licensed_Processes}; and
4.2.0.sec	=	in exceptional circumstances, and in the event that the {_Licensed_Patent_Rights} are Subject Inventions made under a {_CRADA}, the {_Government}, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require {_Licensee} to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the {_Licensed_Patent_Rights} in the Licensed Field of Use on terms that are reasonable under the circumstances, or if {_Licensee} fails to grant this license, the {_Government} retains the right to grant the license itself. The exercise of these rights by the {_Government} shall only be in exceptional circumstances and only if the {_Government} determines:
4.2.1.sec	=	the action is necessary to meet health or safety needs that are not reasonably satisfied by {_Licensee};
4.2.2.sec	=	the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by {_Licensee}; or
4.2.3.sec	=	{_Licensee} has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B); and
4.2.	=	[G/Z/ol-i/s3]
4.3.sec	=	the determination made by the {_Government} under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b).
4.	=	[G/Z/ol-a/s3]
	=	[G/Z/ol/s4]