Ti	=	General Provisions
1.sec	=	Neither party may waive or release any of its rights or interests in {_this_Agreement} except in writing. The failure of the {_Government} to assert a right hereunder or to insist upon compliance with any term or condition of {_this_Agreement} shall not constitute a waiver of that right by the {_Government} or excuse a similar subsequent failure to perform any of these terms or conditions by {_Licensee}.
2.sec	=	{_This_Agreement} constitutes the entire agreement between the parties relating to the subject matter of the {_Licensed_Patent_Rights}, the {_Licensed_Products} and the {_Licensed_Processes}, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by {_this_Agreement}.
3.sec	=	The provisions of {_this_Agreement} are severable, and in the event that any provision of {_this_Agreement} shall be determined to be invalid or unenforceable under any controlling body of law, this determination shall not in any way affect the validity or enforceability of the remaining provisions of {_this_Agreement}.
4.sec	=	If either party desires a modification to {_this_Agreement}, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to {_this_Agreement} or their designees.
5.sec	=	The construction, validity, performance, and effect of {_this_Agreement} shall be governed by Federal law as applied by the Federal courts in the District of Columbia.
6.sec	=	All {_Agreement} notices required or permitted by {_this_Agreement} shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other party at the address designated on the following Signature Page, or to another address as may be designated in writing by the other party. {_Agreement} notices shall be considered timely if the notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.
7.sec	=	{_This_Agreement} shall not be assigned or otherwise transferred (including any transfer by legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other compulsory procedure or order of court) except to {_Licensee}’s {_Affiliate}(s) without the prior written consent of {_IC}. The parties agree that the identity of the parties is material to the formation of {_this_Agreement} and that the obligations under {_this_Agreement} are nondelegable. In the event that {_IC} approves a proposed assignment, {_Licensee} shall pay {_IC}, as an additional royalty, one percent (1%) of the fair market value of any consideration received for any assignment of {_this_Agreement} within sixty (60) days of the assignment.
8.sec	=	{_Licensee} agrees in its use of any {_IC} supplied materials to comply with all applicable statutes, regulations, and guidelines, including {_NIH} and {_HHS} regulations and guidelines. {_Licensee} agrees not to use the materials for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46. {_Licensee} agrees not to use the materials for research involving human subjects or clinical trials outside of the United States without notifying {_IC}, in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to {_IC} of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of the research or trials.
9.sec	=	{_Licensee} acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of these items may require a license from the appropriate agency of the U.S. {_Government} or written assurances by {_Licensee} that it shall not export these items to certain foreign countries without prior approval of this agency. {_IC} neither represents that a license is or is not required or that, if required, it shall be issued.
10.sec	=	{_Licensee} agrees to mark the {_Licensed_Products} or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent Pending” status. All the {_Licensed_Products} manufactured in, shipped to, or sold in other countries shall be marked in a manner to preserve {_IC}’s patent rights in those countries.
11.sec	=	By entering into {_this_Agreement}, {_IC} does not directly or indirectly endorse any product or service provided, or to be provided, by {_Licensee} whether directly or indirectly related to {_this_Agreement}. {_Licensee} shall not state or imply that {_this_Agreement} is an endorsement by the {_Government}, {_IC}, any other {_Government} organizational unit, or any {_Government} employee. Additionally, {_Licensee} shall not use the names of {_IC}, the {_FDA} or the {_HHS} or the {_Government} or their employees in any advertising, promotional, or sales literature without the prior written approval of {_IC}.
12.sec	=	The parties agree to attempt to settle amicably any controversy or claim arising under {_this_Agreement} or a breach of {_this_Agreement}, except for appeals of modifications or termination decisions provided for in Article 13. {_Licensee} agrees first to appeal any unsettled claims or controversies to the designated {_IC} official, or designee, whose decision shall be considered the final agency decision. Thereafter, {_Licensee} may exercise any administrative or judicial remedies that may be available.
13.sec	=	Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to 37 C.F.R. Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant.
14.sec	=	Any formal recordation of {_this_Agreement} required by the laws of any {_Licensed_Territory} as a prerequisite to enforceability of the {_Agreement} in the courts of any foreign jurisdiction or for other reasons shall be carried out by {_Licensee} at its expense, and appropriately verified proof of recordation shall be promptly furnished to {_IC}.
15.sec	=	Paragraphs 4.3, 8.1, 9.5-9.8, 12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of {_this_Agreement} shall survive termination of {_this_Agreement}.
16.sec	=	The terms and conditions of {_this_Agreement} shall, at {_IC}’s sole option, be considered by {_IC} to be withdrawn from {_Licensee}’s consideration and the terms and conditions of {_this_Agreement}, and the {_Agreement} itself to be null and void, unless {_this_Agreement} is executed by {_Licensee} and a fully executed original is received by {_IC} within sixty (60) days from the date of {_IC}’s signature found at the Signature Page.
	=	[G/Z/ol/s16]