Document:

ex_215829.htm

 

EXHIBIT 10.1

 

 

Patent and Biological Materials License Agreement for Internal Research Use with the 

National Institute of Allergy and Infectious Diseases, dated November 25, 2020

 

 

 

Certain information as identified herein has been omitted from this exhibit because it is

both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

 

 

 

 

 

 

 

PUBLIC HEALTH SERVICE

 

NON-EXCLUSIVE PATENT and BIOLOGICAL MATERIALS LICENSE AGREEMENT

FOR INTERNAL RESEARCH USE

 

This Agreement is based on the model Non-Exclusive Patent Internal Use Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).

 

 

 

This Cover Page identifies the Parties to this Agreement:

 

 

 

The U.S. Department of Health and Human Services, as represented by

 

National Institute of Allergy and Infectious Diseases,

 

an Institute or Center (hereinafter referred to as the “IC”) of the

 

NIH

 

 

 

and

 

 

 

GeoVax Inc., hereinafter referred to as the “Licensee”,

 

having offices at 1900 Lake Park Dr., Ste.380, Smyrna, Georgia 30080,

 

created and operating under the laws of Georgia, United States of America.

 

Tax ID No. : 58-2646816

 

 

 

 

 

For IC’s internal use only:

 

 

License Number: L-243-2020-0

 

 

License Application Number: A-411-2020

 

 

 

Serial Number(s) of Licensed Patent(s) or Patent Application(s): Appendix A

 

 

 

Cooperative Research and Development Agreement (CRADA) Number (if a subject invention): N/A

 

 

 

Additional Remarks: N/A

 

 

 

Public Benefit(s): Novel therapeutics may be developed using a recombinant MVA platform.

 

 

 

This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Licensed Products, Processes, Territory, Field of Use and Termination), Appendix C (Royalties), and Appendix D (Royalty Payment Options).

 

 

 

 

The IC and the Licensee agree as follows:

 

	
			1.

				
			BACKGROUND

			

 

	 	
			1.1

				
			In the course of conducting biomedical and behavioral research, the IC investigators made inventions that may have commercial applicability.

			

 

	 	
			1.2

				
			By assignment of rights from the IC employees and other inventors, HHS, on behalf of the Government, owns intellectual property rights claimed in any United States or foreign patent applications or patents corresponding to the assigned inventions. HHS also owns any tangible embodiments of these inventions actually reduced to practice by the IC.

			

 

	 	
			1.3

				
			The Secretary of HHS has delegated to the IC the authority to enter into this Agreement for the licensing of rights to these inventions under 35 U.S.C. §§200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. §3710a, and the regulations governing the licensing of Government-owned inventions, 37 C.F.R. Part 404.

			

 

	 	
			1.4

				
			The IC desires to transfer these inventions to the private sector through commercial research licenses to facilitate the commercial development of products and processes for public use and benefit.

			

 

	 	
			1.5

				
			The Licensee desires to acquire the rights to use certain of these inventions in order to develop processes, methods, or marketable products for public use and benefit.

			

 

	
			2.

				
			DEFINITIONS

			

 

	 	
			2.1

				
			“Affiliate(s)” means a corporation or other business entity, which directly or indirectly is controlled by or controls, or is under common control with the Licensee. For this purpose, the term "control" shall mean ownership of more than fifty percent (50%) of the voting stock or other ownership interest of the corporation or other business entity, or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other business entity.

			

 

	 	
			2.2

				
			“Government” means the government of the United States of America.

			

 

	 	
			2.3

				
			“Licensed Patent Rights” shall mean:

			

 

	 	
			(a)

				
			U.S. patent applications and patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;

			

 

	 	
			(b)

				
			to the extent that the following contain one or more claims directed to the invention or inventions claimed in 2.3(a):

			

 

	 	
			(i)

				
			continuations-in-part of 2.3(a);

			

 

	 	
			(ii)

				
			all divisions and continuations of these continuations-in-part;

			

 

	 	
			(iii)

				
			all patents issuing from these continuations-in-part, divisions, and continuations; and

			

 

	 	
			(iv)

				
			any reissues, reexaminations, and extensions of these patents;

			

 

 

 

 

	 	
			(c)

				
			to the extent that the following contain one or more claims directed to the invention or inventions claimed in 2.3(a): all counterpart foreign applications and patents to 2.3(a) and 2.3(b), including those listed in Appendix A; and

			

 

	 	
			(d)

				
			Licensed Patent Rights shall not include 2.3(b) or 2.3(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter of a claim in 2.3(a).

			

 

	 	
			2.4

				
			“Licensed Products” means tangible materials, which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

			

 

	 	
			2.5

				
			“Licensed Processes” means processes, which, in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

			

 

	 	
			2.6

				
			“Licensed Territory” means the geographical area identified in Appendix B.

			

 

	 	
			2.7

				
			“Licensed Fields of Use” means the field of use identified in Appendix B.

			

 

	 	
			2.8

				
			“Materials” means the following tangible materials and all progeny, subclones and/or unmodified derivatives thereof:

			

 

	 	
			(a)

				
			plasmid shuttle vector pLW-76 (as described in HHS reference number E-018-2010/0), and

			

 

	 	
			(b)

				
			plasmid shuttle vector pLW-73 (as described in HHS reference number E-248-2006/0) and referenced in the publication Wyatt, L., et al, Elucidating and minimizing the loss by recombinant vaccinia virus of human immunodeficiency virus gene expression resulting from spontaneous mutations and positive selections. Journal of Virology 83: 7176-7184. (PMID: 19420086).

			

 

	
			3.

				
			GRANT OF RIGHTS

			

 

	 	
			3.1

				
			The IC hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, a nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make and to use, but not to sell Materials, Licensed Products and Licensed Processes in the Licensed Fields of Use.

			

 

	 	
			3.2

				
			The Licensee has no right to sublicense.

			

 

	 	
			3.3

				
			This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of the IC other than the Licensed Patent Rights regardless of whether such patents are dominant or subordinate to the Licensed Patent Rights.

			

 

	 	
			3.4

				
			The IC acknowledges that information relating to the Licensed Patent Rights may be of assistance to the Licensee in its research efforts. Accordingly, the IC shall consider reasonable requests by the Licensee for access to the inventors of the Licensed Patent Rights.

			

 

 

 

 

	
			4.

				
			ROYALTIES

			

 

	 	
			4.1

				
			The Licensee agrees to pay the IC a non-creditable, nonrefundable license issue royalty as set forth in Appendix C.

			

 

	 	
			4.2

				
			The Licensee agrees to pay the IC a nonrefundable annual royalty as set forth in Appendix C.

			

 

	 	
			4.3

				
			All royalties due under this Agreement shall be paid in U.S. dollars, net of all non-U.S. taxes, and payment options are listed in Appendix D. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wall Street Journal on the day that the payment is due.

			

 

	 	
			4.4

				
			Additional royalties may be assessed by the IC on any payment that is more than ninety (90) days overdue at the rate of one percent (1%) per month. This one percent (1%) per month rate may be applied retroactively from the original due date until the date of receipt by the IC of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent the IC from exercising any other rights it may have as a consequence of the lateness of any payment.

			

 

	 	
			4.5

				
			No royalties due under this Agreement shall be paid with funds stemming from any federal contract, grant, or cooperative agreement.

			

 

	
			5.

				
			PERFORMANCE

			

 

	 	
			5.1

				
			The IC has previously provided Materials to the Licensee, and this Agreement aims to document that transfer and appropriately link Materials to the provisions of this Agreement. The IC agrees to replace the Materials, as available, at reasonable cost, in the event of their unintentional destruction. The Licensee agrees to retain control over the Licensed Products and shall not distribute or release them to others without the prior written consent of the IC.

			

 

	 	
			5.2

				
			The Licensee shall expend reasonable efforts and resources to carry out the research development plan submitted with the Licensee's application for a license and shall begin research within six (6) months of the effective date of this Agreement.

			

 

	 	
			5.3

				
			The Licensee agrees in its use of any Materials and Licensed Products provided by the IC to comply with all applicable statutes, regulations, and guidelines, including NIH and HHS regulations and guidelines. The Licensee agrees not to use the Materials and the Licensed Products 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. The Licensee agrees not to use the Materials and the Licensed Products for research involving human subjects or clinical trials outside of the United States without notifying the IC, in writing, of this research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to the 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 this research or trials.

			

 

	 	
			5.4

				
			All plans and reports required by this Agreement shall be treated by the IC as commercial and financial information obtained from a person and as privileged and confidential and, to the extent permitted by law, not subject to disclosure under the Freedom of Information Act, 5 U.S.C. §552.

			

 

 

	
			6.

				
			NEGATION OF WARRANTIES AND INDEMNIFICATION

			

 

	 	
			6.1

				
			The IC offers no warranties other than those expressly specified in Article 1.

			

 

 

 

 

	 	
			6.2

				
			The IC does not warrant the validity of the Licensed Patent Rights and makes no representations whatsoever with regard to the scope of the Licensed Patent Rights, or that the Licensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties.

			

 

	 	
			6.3

				
			THE IC MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR OF ANY MATERIALS OR LICENSED PRODUCTS PROVIDED TO THE LICENSEE UNDER PARAGRAPH 5.1.

			

 

	 	
			6.4

				
			The IC does not represent that it shall commence legal actions against third parties infringing the Licensed Patent Rights.

			

 

	 	
			6.5

				
			The Licensee shall indemnify and hold the IC, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of:

			

 

	 	
			(a)

				
			the use by the Licensee, its directors, employees, or third parties of any Licensed Patent Rights, or

			

 

	 	
			(b)

				
			the design, manufacture, distribution, or use of any Materials and Licensed Products provided under Paragraph 5.1, or other products or processes developed in connection with or arising out of the Licensed Patent Rights.

			

 

	 	
			6.6

				
			The Licensee agrees to maintain a liability insurance program consistent with sound business practice.

			

 

	
			7.

				
			TERM, TERMINATION AND MODIFICATION OF RIGHTS

			

 

	 	
			7.1

				
			This Agreement is effective when signed by all parties, unless the provisions of Paragraph 8.8 are not fulfilled, and shall expire at the time specified in Appendix B, unless previously terminated under the terms of this Article 7.

			

 

	 	
			7.2

				
			In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 7.3 and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.

			

 

	 	
			7.3

				
			The IC shall specifically have the right to terminate this Agreement by written notice if the Licensee:

			

 

	 	
			(a)

				
			has not demonstrated that it is executing the research plan submitted with its application for a license or that it has not taken or cannot be expected to take, within a reasonable time, effective steps to achieve the practical application of the Licensed Patent Rights as contemplated by this Agreement; or

			

 

	 	
			(b)

				
			has willfully made a false statement of or willfully omitted a material fact in its application for a license or in any report required by this Agreement.

			

 

 

 

 

	 	
			7.4

				
			The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by Federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.

			

 

	 	
			7.5

				
			The Licensee shall have a unilateral right to terminate this Agreement by giving the IC sixty (60) days written notice to that effect.

			

 

	 	
			7.6

				
			Within thirty (30) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be accessible.

			

 

	 	
			7.7

				
			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.

			

 

	 	
			7.8

				
			Within ninety (90) days of expiration, termination or term extension of this Agreement under this Article 7, a final report shall be submitted by the Licensee. The Licensee shall send the report to the IC at the Mailing Address for Agreement notices indicated on the Signature Page.

			

 

	 	
			(a)

				
			The report shall include, but not be limited to, progress on the research and development involving the Licensed Patent Rights, the Materials, the Licensed Products or the Licensed Processes.

			

 

	 	
			(b)

				
			Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty) due to the IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Materials and Licensed Products to the IC or provide the IC with written certification of their destruction, unless the Licensee has executed a commercialization license for the Licensed Patent Rights or Licensed Products..

			

 

	 	
			(c)

				
			If the term of the Agreement is extended at the Licensee’s request, then the IC and the Licensee will negotiate in good faith regarding the schedule for reports regarding the information required in 7.8(a);

			

 

	 	
			(d)

				
			If the term of this Agreement is longer than ten (10) years, then the IC may request a status update report after the fifth (5th) year of the Agreement; and

			

 

	 	
			(e)

				
			The Licensee may not be granted additional IC licenses if this reporting requirement is not fulfilled.

			

 

	 	
			7.9

				
			Paragraphs 4.3, 4.4, 4.5, 5.4, 6.1-6.5, 7.6, 7.8 and 7.9 of this Agreement shall survive termination of this Agreement.

			

 

 

 

 

	
			8.

				
			GENERAL PROVISIONS

			

 

	 	
			8.1

				
			This Agreement constitutes the entire agreement between the parties relating to the subject matter of the Licensed Patent Rights, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement.

			

 

	 	
			8.2

				
			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, such determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement.

			

 

	 	
			8.3

				
			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.

			

 

	 	
			8.4

				
			All Agreement notices required or permitted by this Agreement shall be given by prepaid, first class, registered or certified mail 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 such other party, and shall be effective as of the date of the postmark of such notice.

			

 

	 	
			8.5

				
			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 the Licensee’s Affiliate(s) without the prior written consent of the 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.

			

 

	 	
			8.6

				
			The 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 materials and other commodities. The transfer of these items may require a license from the appropriate agency of the Government or written assurances by the Licensee that it shall not export these items to certain foreign countries without prior approval of the agency. The IC neither represents that a license is or is not required or that, if required, it shall be issued.

			

 

	 	
			8.7

				
			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 modification or termination decisions provided for in Article 7. The Licensee agrees first to appeal any such unsettled claims or controversies to the designated IC official, or designee, whose decision shall be considered the final agency decision. Thereafter, the Licensee may exercise any administrative or judicial remedies that may be available.

			

 

	 	
			8.8

				
			The terms and conditions of this Agreement shall, at the IC’s sole option, be considered by the IC to be withdrawn from the 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 the Licensee and a fully executed original is received by the IC within sixty (60) days from the date of the IC signature found at the Signature Page.

			

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

 

 

NIH NON-EXCLUSIVE PATENT LICENSE AGREEMENT

FOR INTERNAL RESEARCH USE

 

FOR IC:

 

 

	by:                                                                                      	                               
	
			Michael Mowatt, Ph.D.

				
			                              Date

			

Director, Technology Transfer and Intellectual Property Office

National Institute of Allergy and Infectious Diseases; National Institutes of Health

 

Mailing Address or E-mail Address for Agreement notices and reports:

 

License Compliance and Administration

Monitoring & Enforcement

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland  20852-3804 U.S.A.

 

 

E-mail: LicenseNotices_Reports@mail.nih.gov

 

 

For the Licensee (Upon information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the Licensee made or referred to in this document are truthful and accurate.):

 

Licensee

 

	by:                                                                                 	                                   
	Signature of Authorized Official	Date

  

David A. Dodd    

Printed Name

 

Chairmand and CEO

Title

 

 

	 	
			I.

				
			Official and Mailing Address for Agreement notices:

			

 

Mr. David A. Dodd

Chairman and CEO

GeoVax, Inc.

1900 Lake Park Drive

Suite 380

Smyrna, GA 30080

678-384-7222

ddodd@geovax.com

 

E-mail address: ddodd@geovax.com

 

 

 

 

	 	
			II.

				
			Official and Mailing Address for Financial notices (Licensee’s contact person for royalty payments)

			

 

Mr. Mark W. Reynolds

Chief Financial Officer

GeoVax, Inc.

1900 Lake Park Drive

Suite 380

Smyrna, GA 30080

678-384-7224

mreynolds@geovax.com

 

E-mail address: mreynolds@geovax.com

 

Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).

 

 

 

 

APPENDIX A – Patent(s) or Patent Application(s)

 

Patent(s) or Patent Application(s):

 

E-552-1982 technology:

 

	
			HHS Ref. No.

				
			Territory

				
			Application No.

				
			Patent No.

			
	
			E-552-1982-2-US-03

				
			United States

				
			07/987,546

				
			7045313

			
	
			E-552-1982-2-US-04

				
			United States

				
			08/470,357

				
			7015024

			
	
			E-552-1982-2-US-06

				
			United States

				
			08/470,360

				
			6998252

			
	
			E-552-1982-2-US-05

				
			United States

				
			08/470,359

				
			7045136

			

 

 

E-018-2010 technology:

 

	
			HHS Ref. No.

				
			Territory

				
			Application No.

				
			Patent No.

			
	
			E-018-2010-0-US-08

				
			United States

				
			13/502,205

				
			9,133,480

			
	
			E-018-2010-0-US-10

				
			United States

				
			14/837,382

				
			9,879,231

			

 

 

E-248-2006 technology:

 

	
			HHS Ref. No.

				
			Territory

				
			Application No.

				
			Patent No.

			
	
			E-248-2006-0-US-05

				
			United States

				
			12/377,847

				
			9,133,478

			
	
			E-248-2006-0-US-19

				
			United States

				
			14/833,913

				
			10,421,978

			
	
			E-248-2006-0-US-26

				
			United States

				
			16/579,276

				
			*presently pending

			

 

 

 

 

APPENDIX B – Licensed Products, Processes, Territory, Field of Use and Termination

 

	
			I.

				
			Licensed Territory:

			

 

Facilities of Licensee and Licensee’s contractors within the United States.

 

	
			II.

				
			Licensed Fields of Use:

			

 

	 	
			(a)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic Ebola-Zaire vaccine or booster that expresses Ebola-Zaire surface glycoprotein (GP) antigen cloned into a first insertion site and Ebola-Zaire VP40 matrix protein antigen cloned into a second insertion site;

			

 

	 	
			(b)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic Ebola-Sudan vaccine or booster that expresses Ebola-Sudan surface glycoprotein (GP) antigen cloned into a first insertion site and Ebola-Zaire VP40 matrix protein antigen cloned into a second insertion site;

			

 

	 	
			(c)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic Lassa virus vaccine or booster that expresses Lassa surface glycoprotein (GP) antigen cloned into a first insertion site and Lassa Z matrix protein antigen cloned into a second insertion site;

			

 

	 	
			(d)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic Marburg virus vaccine or booster that expresses Marburg surface glycoprotein (GP) antigen cloned into a first insertion site and Marburg VP 40 matrix protein antigen cloned into a second insertion site of MVA;

			

 

	 	
			(e)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic oncology MVA-VLP vaccine or booster that expresses tumor associated antigen MUC1 in a highly immunogenic format and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(f)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a therapeutic oncology MVA-VLP vaccine or booster that expresses CyclinB1 and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(g)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive Modified Vaccinia Ankara vaccine or booster against Zika virus that expresses NS1 antigen from Zika virus;

			

 

 

 

 

	 	
			(h)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA “malaria” vaccine or booster expressing one (1) Pfs230 antigen of Plasmodium (parasite) (falciparum) and one (1) circumsporozoite protein (CSP) antigen of Plasmodium (parasite) (falciparum) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(i)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA “malaria” vaccine or booster expressing one (1) circumsporozoite protein (CSP) antigen of Plasmodium (parasite) (yoelli) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(j)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA-VLP “malaria” vaccine or booster expressing one (1) circumsporozoite protein (CSP) antigen of Plasmodium (parasite) (falciparum) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(k)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA-VLP “malaria” vaccine or booster expressing one (1) sporozoite micronemal protein essential for cell traversal (SPECT2) antigen of Plasmodium (parasite) (falciparum) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(l)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA-VLP “malaria” vaccine or booster expressing one (1) GTP-binding protein, putative (PF3D7_1462300) antigen of Plasmodium (parasite) (falciparum) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus);

			

 

	 	
			(m)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with Licensee’s proprietary technology for the creation of a preventive MVA-VLP “malaria” vaccine or booster expressing one (1) antigen encoded by the PF3D7_0813400 gene of Plasmodium (parasite) (falciparum) and which also expresses at least one (1) viral matrix protein (Vp40 of Marburg virus); and,

			

 

	 	
			(n)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with combination with Licensee’s proprietary technology for the creation of a MVA expressing at least one (1) “L-01 microtide” peptide capable of acting as a checkpoint inhibitor for use as an adjuvant in a vaccine strategy; and,

			

 

	 	
			(o)

				
			Non-clinical development and non-clinical use of Licensed Patent Rights in combination with combination with Licensee’s proprietary technology for the creation of a MVA expressing at least one (1) “L-10 microtide” peptide capable of acting as a checkpoint inhibitor for use as an adjuvant in a vaccine strategy.

			

 

	
			III.

				
			Termination:

			

 

	 	
			(a)

				
			This Agreement shall expire ten (10) years from the effective date as defined in Paragraph 7.1 unless previously terminated under Article 7.

			

 

 

 

 

APPENDIX C – Royalties

 

[This appendix has been redacted in its entirety]

 

 

 

 

Appendix D – Royalty Payment Options

New Payment Options Effective March 2018

 

The License Number MUST appear on payments, reports and correspondence.

 

Credit and Debit Card Payments: Credit and debit card payments can be submitted for amounts up to $24,999. Submit your payment through the U.S. Treasury web site located at: https://www.pay.gov/public/form/start/28680443.

 

Automated Clearing House (ACH) for payments through U.S. banks only

 

The IC encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH). Submit your ACH payment through the U.S. Treasury web site located at: https://www.pay.gov/public/form/start/28680443. Please note that the IC "only" accepts ACH payments through this U.S. Treasury web site.

 

Electronic Funds Wire Transfers: The following account information is provided for wire payments. In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following information within the transmission:

 

Drawn on a U.S. bank account via FEDWIRE:

 

Please provide the following instructions to your Financial Institution for the remittance of Fedwire payments to the NIH ROYALTY FUND.

 

	
			Fedwire

			Field Tag

				
			Fedwire Field Name

				
			Required Information

			
	 
	
			{1510}

				
			Type/Subtype

				
			1000

			
	
			{2000}

				
			Amount

				
			(enter payment amount)

			
	
			{3400}

				
			Receiver ABA routing number*

				
			021030004

			
	
			{3400}

				
			Receiver ABA short name

				
			TREAS NYC

			
	
			{3600}

				
			Business Function Code

				
			CTR (or CTP)

			
	
			{4200}

				
			Beneficiary Identifier (account number)

				
			(enter 12 digit gateway account #)

			875080031006

			
	
			{4200}

				
			Beneficiary Name

				
			(enter agency name associated with the Beneficiary Identifier)

			DHHS / NIH (75080031)

			
	
			{5000}

				
			Originator

				
			(enter the name of the originator of the payment)

			COMPANY NAME

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 1

				
			(enter information to identify the purpose of the payment)

			ROYALTY

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 2

				
			(enter information to identify the purpose of the payment)

			LICENSE NUMBER

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 3

				
			(enter information to identify the purpose of the payment)

			INVOICE NUMBER

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 4

				
			(enter information to identify the purpose of the payment)

			
	
			Notes:

			*The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045.

			

 

 

 

 

Agency Contacts: Office of Technology Transfer (OTT) (301) 496-7057 OTT-Royalties@mail.nih.gov

 

Drawn on a foreign bank account via FEDWIRE:

 

The following instructions pertain to the Fedwire Network. Deposits made in US Dollars (USD).

 

Should your remitter utilize a correspondent US domestic bank in transferring electronic funds, the following Fedwire instructions are applicable.

 

	
			Fedwire

			Field Tag

				
			Fedwire Field Name

				
			Required Information

			
	 
	
			{1510}

				
			Type/Subtype

				
			1000

			
	
			{2000}

				
			Amount

				
			(enter payment amount)

			
	
			{3100}

				
			Sender Bank ABA routing number

				
			(enter the US correspondent bank’s ABA routing number)

			
	
			{3400}

				
			Receiver ABA routing number*

				
			021030004

			
	
			{3400}

				
			Receiver ABA short name

				
			TREAS NYC

			
	
			{3600}

				
			Business Function Code

				
			CTR (or CTP)

			
	
			{4200}

				
			Beneficiary Identifier (account number)**

				
			(enter 12 digit gateway account #)

			875080031006

			
	
			{4200}

				
			Beneficiary Name

				
			(enter agency name associated with the Beneficiary Identifier)

			DHHS / NIH (75080031)

			
	
			{5000}

				
			Originator

				
			(enter the name of the originator of the payment)

			COMPANY’S NAME

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 1

				
			(enter information to identify the purpose of the payment)

			ROYALTY

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 2

				
			(enter information to identify the purpose of the payment)

			LICENSE NUMBER

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 3

				
			(enter information to identify the purpose of the payment)

			INVOICE NUMBER

			
	
			{6000}

				
			Originator to Beneficiary Information – Line 4

				
			(enter information to identify the purpose of the payment)

			
	
			Notes:

			*The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045.

			**Anything other than the 12 digit gateway account # will cause the Fedwire to be returned – SWIFT CODE: FRNYUS33

			

 

Agency Contacts:

 

Office of Technology Transfer (OTT)     (301) 496-7057     OTT-Royalties@mail.nih.gov

 

Checks

 

All checks should be made payable to “NIH Patent Licensing”

 

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address:

 

National Institutes of Health

P.O. Box 979071

St. Louis, MO 63197-9000

 

 

 

 

Checks drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:

 

US Bank

Government Lockbox SL-MO-C2GL

1005 Convention Plaza

St. Louis, MO 63101

Phone: 314-418-4087

 

Checks drawn on a foreign bank account should be sent directly to the following address:

 

National Institutes of Health

Office of Technology Transfer

License Compliance and Administration

Royalty Administration

6011 Executive Boulevard

Suite 325, MSC 7660

Rockville, Maryland 20852achv-ex411_234.htm

 

Exhibit 4.11

ACHIEVE LIFE SCIENCES, INC. 
WARRANT

Warrant No. Original Issue Date: December [  ], 2020

Achieve Life Sciences, Inc., a Delaware corporation (the "Company"), hereby certifies that, as partial compensation for its services as an underwriter to the Company, Lake Street Capital Markets, LLC or its registered assigns (the "Holder") is entitled to purchase from the Company up to a total of [     ]1 shares of the Company's common stock, par value $0.001 per share (the "Common Stock"), at any time and from time to time from and after 180 days following the effective date of the Registration Statement on Form S-1 (File No. 333-250074), and through and including December [  ], 2025, the fifth anniversary of such effective date (the "Expiration Date"), in accordance with FINRA Rule 5110, and subject to the following terms and conditions:

1.Definitions. As used in this Warrant, the following terms shall have the respective definitions set forth in this Section 1.

  

"Affiliate" means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144.

"Business Day" means any day except Saturday, Sunday and any day which is a federal legal holiday or a day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.

"Common Stock" means the common stock of the Company, par value $0.001 per share, and any securities into which such common stock may hereafter be reclassified or for which it may be exchanged as a class.

"Exchange Act" means the Securities Exchange Act of 1934, as amended. "Exercise Price" means $[    ], subject to adjustment in accordance with Section 9.

"Fundamental Transaction" means any of the following: (1) the Company effects any merger or consolidation of the Company with or into another Person, (2) the Company effects any sale of all or substantially all of its assets in one or a series of related transactions, (3) any tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to tender or exchange their shares for other 

	
	 

	
1 
	
 3% of the number of shares of Common Stock sold at the Closing, which shall not exceed 50,000 shares of Common Stock

 

 

securities, cash or property, or (4) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property.

"New York Courts" means the state and federal courts sitting in the State of New York.

"Original Issue Date" means the Original Issue Date first set forth on the first page of this Warrant.

"Person" means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

"Prospectus" means the prospectus, dated [     ], 2020, filed with the Securities and Exchange Commission pursuant to Rule 424(b) promulgated under the Securities Act.

"Rule 144" means Rule 144 promulgated by the Securities and Exchange Commission pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Securities and Exchange Commission having substantially the same effect as such Rule.

"Securities Act" means the Securities Act of 1933, as amended.

 

"Subsidiary" means any "significant subsidiary" as defined in Rule 1-02(w) of Regulation S-X promulgated by the Securities and Exchange Commission under the Exchange Act.

"Trading Day" means (i) a day on which the Common Stock is traded on a Trading Market, or (ii) if the Common Stock is not quoted on any Trading Market, a day on which the Common Stock is quoted in the over-the-counter market as reported by the Pink Sheets LLC (or any similar organization or agency succeeding to its functions of reporting prices); provided, that in the event that the Common Stock is not listed or quoted as set forth in (i) or (ii) hereof, then Trading Day shall mean a Business Day.

"Trading Market" means whichever of the New York Stock Exchange, the NYSE MKT, the NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market or OTC Markets Group electronic quotation system on which the Common Stock is listed or quoted for trading on the date in question.

"Underlying Shares" means the shares of Common Stock issuable upon exercise of this Warrant.

2.Registration of Warrant. The Company shall register this Warrant upon records to be maintained by the Company for that purpose (the "Warrant Register"), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

3.Registration of Transfers. The Company shall register the transfer of any portion of this Warrant in the Warrant Register, upon surrender of this Warrant, with the Form of Assignment attached hereto duly completed and signed, to the Company at its address specified herein. Upon 

 

 

any such registration or transfer, a new Warrant to purchase Common Stock, in substantially the form of this Warrant (any such new Warrant, a "New Warrant"), evidencing the portion of this Warrant so transferred shall be issued to the transferee and a New Warrant evidencing the remaining portion of this Warrant not so transferred, if any, shall be issued to the transferring Holder. The acceptance of the New Warrant by the transferee thereof shall be deemed the acceptance by such transferee of all of the rights and obligations of a holder of a Warrant.  Notwithstanding the foregoing, neither this Warrant nor any shares of Common Stock issuable upon exercise of this Warrant, shall be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of this Warrant, or any security issuable upon exercise of this Warrant, by any person for a period of 180 days immediately following the effective date of the Registration Statement on Form S-1 (File No. 333-250074), except as provided in FINRA Rule 5110(g)(2).

 

4.Exercise and Duration of Warrants. This Warrant shall be exercisable by the registered Holder at any time and from time to time from and after 180 days following the effective date of the Registration Statement on Form S-1 (File No. 333-250074) (the "Effective Date"), through and including the Expiration Date, in accordance with FINRA Rule 5110. At 6:30 p.m., New York City time on the Expiration Date, the portion of this Warrant not exercised prior thereto shall be and become void and of no value. The Company may not call or redeem any portion of this Warrant without the prior written consent of the affected Holder. Neither this Warrant nor any shares of Common Stock issuable upon exercise of this Warrant, shall be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of this Warrant, or any security issuable upon exercise of this Warrant, by any person for a period of 180 days immediately following the Effective Date, except as provided in FINRA Rule 5110(g)(2).  

 

5.Delivery of Common Stock.

(a)To effect exercises hereunder, the Holder shall not be required to physically surrender this Warrant unless all of the Warrant Shares represented by this Warrant are being exercised. Upon delivery of the Exercise Notice (in the form attached hereto) to the Company (with the attached Warrant Shares Exercise Log) at its address for notice set forth herein and upon payment of the Exercise Price multiplied by the number of Warrant Shares that the Holder intends to purchase hereunder, the Company shall promptly (but in no event later than two Trading Days after the Date of Exercise (as defined herein)) issue and deliver to the Holder, a certificate for the Warrant Shares issuable upon such exercise. The Company shall, upon request of the Holder and subject to there being available an effective registration statement registering, or a current prospectus available for, the issuance or resale of the Warrant Shares, use its reasonable best efforts to deliver Warrant Shares hereunder electronically through the Depository Trust Corporation or another established clearing corporation performing similar functions, if available, provided, that, the Company may, but will not be required to change its transfer agent if its current transfer agent cannot deliver Warrant Shares electronically through the Depository Trust Corporation. A "Date of Exercise" means the date on which the Holder shall have delivered to the Company: (i) the Exercise Notice (with the Warrant Shares Exercise Log attached to it), appropriately completed and duly signed and (ii) if applicable, payment of the Exercise Price for the number of Warrant Shares so indicated by the Holder to be purchased.

 

 

(b)If by the second Trading Day after a Date of Exercise the Company fails to deliver the required number of Warrant Shares in the manner required pursuant to Section 5(a), then the Holder will have the right to rescind such exercise.

 

(c)If by the second Trading Day after a Date of Exercise the Company fails to deliver the required number of Warrant Shares in the manner required pursuant to Section 5(a), and if after such second Trading Day and prior to the receipt of such Warrant Shares, the Holder purchases (in an open market transaction or otherwise) shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a "Buy-In"), then the Company shall (1) reimburse the Holder the amount by which (x) the Holder's total purchase price (including brokerage commissions, if any) for the shares of Common Stock or Warrants so purchased exceeds (y) the amount obtained by multiplying (A) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue by (B) the closing bid price of the shares of Common Stock, on the Date of Exercise and (2) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In.

 

 (d)The Company's obligations to issue and deliver Warrant Shares in accordance with the terms hereof are absolute and unconditional, irrespective of any action or inaction by the Holder to enforce the same, any waiver or consent with respect to any provision hereof, the recovery of any judgment against any Person or any action to enforce the same, or any setoff, counterclaim, recoupment, limitation or termination, or any breach or alleged breach by the Holder or any other Person of any obligation to the Company or any violation or alleged violation of law by the Holder or any other Person, and irrespective of any other circumstance which might otherwise limit such obligation of the Company to the Holder in connection with the issuance of Warrant Shares. Nothing herein shall limit a Holder's right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company's failure to timely deliver certificates representing Warrant Shares upon exercise of the Warrant as required pursuant to the terms hereof.

 

6.Charges, Taxes and Expenses. Issuance and delivery of Warrant Shares upon exercise of this Warrant shall be made without charge to the Holder for any issue or transfer tax, withholding tax, transfer agent fee or other incidental tax or expense in respect of the issuance of such certificates, all of which taxes and expenses shall be paid by the Company; provided, however, that the Company shall not be required to pay any tax which may be payable in respect of any transfer involved in the registration of any certificates for Warrant Shares or Warrants in a name other than that of the Holder. The Holder shall be responsible for all other tax liability that may arise as a result of holding or transferring this Warrant or receiving Warrant Shares upon exercise hereof.

 

7.Replacement of Warrant. If this Warrant is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation hereof, or in lieu of and substitution for this Warrant, a New Warrant, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction and customary 

 

 

and reasonable indemnity (which shall not include a surety bond), if requested. Applicants for a New Warrant under such circumstances shall also comply with such other reasonable regulations and procedures and pay such other reasonable third-party costs as the Company may prescribe. If a New Warrant is requested as a result of a mutilation of this Warrant, then the Holder shall deliver such mutilated Warrant to the Company as a condition precedent to the Company's obligation to issue the New Warrant.

 

8.Reservation of Warrant Shares. The Company covenants that it will at all times reserve and keep available out of the aggregate of its authorized but unissued and otherwise unreserved shares of Common Stock, solely for the purpose of enabling it to issue Warrant Shares upon exercise of this Warrant as herein provided, the number of shares of Common Stock which are then issuable and deliverable upon the exercise of this entire Warrant, free from preemptive rights or any other contingent purchase rights of Persons other than the Holder (taking into account the adjustments and restrictions of Section 9). The Company covenants that all Warrant Shares so issuable and deliverable shall, upon issuance and the payment of the applicable Exercise Price in accordance with the terms hereof, be duly and validly authorized, issued and fully paid and nonassessable.

 

9.Certain Adjustments. The Exercise Price and number of Warrant Shares issuable upon exercise of this Warrant are subject to adjustment from time to time as set forth in this Section 9.

(a)Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding, (i) pays a stock dividend on its Common Stock or otherwise makes a distribution on any class of capital stock that is payable in shares of Common Stock, (ii) subdivides outstanding shares of Common Stock into a larger number of shares, or (iii) combines outstanding shares of Common Stock into a smaller number of shares, then in each such case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to clause (i) of this paragraph shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution, and any adjustment pursuant to clause (ii) or (iii) of this paragraph shall become effective immediately after the effective date of such subdivision or combination.

(b)Fundamental Transactions. If, at any time while this Warrant is outstanding there is a Fundamental Transaction, then the Holder shall have the right thereafter to receive, upon exercise of this Warrant, the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of the number of Warrant Shares then issuable upon exercise in full of this Warrant (the "Alternate Consideration"). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental 

 

 

Transaction. At the Holder's option and request, any successor to the Company or surviving entity in such Fundamental Transaction shall issue to the Holder a new warrant substantially in the form of this Warrant and consistent with the foregoing provisions and evidencing the Holder's right to purchase the Alternate Consideration for the aggregate Exercise Price upon exercise thereof. The terms of any agreement pursuant to which a Fundamental Transaction is effected shall include terms requiring any such successor or surviving entity to comply with the provisions of this paragraph (b) and insuring that the Warrant (or any such replacement security) will be similarly adjusted upon any subsequent transaction analogous to a Fundamental Transaction.

(c)Number of Warrant Shares. Simultaneously with any adjustment to the Exercise Price pursuant to this Section 9, the number of Warrant Shares that may be purchased upon exercise of this Warrant shall be increased or decreased proportionately, so that after such adjustment the aggregate Exercise Price payable hereunder for the adjusted number of Warrant Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment.

 

(d)Calculations. All calculations under this Section 9 shall be made to the nearest cent or the nearest 1/100th of a share, as applicable. The number of shares of Common Stock outstanding at any given time shall not include shares owned or held by or for the account of the Company, and the disposition of any such shares shall be considered an issue or sale of Common Stock.

 

(e)Notice of Adjustments. Upon the occurrence of each adjustment pursuant to this Section 9, the Company at its expense will promptly compute such adjustment in accordance with the terms of this Warrant and prepare a certificate setting forth such adjustment, including a statement of the adjusted Exercise Price and adjusted number or type of Warrant Shares or other securities issuable upon exercise of this Warrant (as applicable), describing the transactions giving rise to such adjustments and showing in detail the facts upon which such adjustment is based. Upon written request, the Company will promptly deliver a copy of each such certificate to the Holder and to the Company's Transfer Agent.

(f)Notice of Corporate Events. If the Company (i) declares a dividend or any other distribution of cash, securities or other property in respect of its Common Stock, including, without limitation, any granting of rights or warrants to subscribe for or purchase any capital stock of the Company or any Subsidiary, (ii) authorizes or approves, enters into any agreement contemplating or solicits stockholder approval for any Fundamental Transaction or (iii) authorizes the voluntary dissolution, liquidation or winding up of the affairs of the Company, then the Company shall deliver to the Holder a notice describing the material terms and conditions of such transaction (but only to the extent such disclosure would not result in the dissemination of material, non-public information to the Holder) at least 10 calendar days prior to the applicable record or effective date on which a Person would need to hold Common Stock in order to participate in or vote with respect to such transaction, and the Company will take all steps reasonably necessary in order to insure that the Holder is given the practical opportunity to exercise this Warrant prior to such time so as to participate in or vote with respect to such transaction; provided, however, that the failure to deliver such notice or any defect therein shall not affect the validity of the corporate action required to be described in such notice.

10.Payment of Exercise Price. The Holder may pay the Exercise Price in one of the following manners:

 

 

(a)Cash Exercise. The Holder may deliver immediately available funds; or

(b)Cashless Exercise. If at the time of exercise hereof there is no effective registration statement registering, or no current prospectus available for, the issuance or resale of the Warrant Shares by the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares determined as follows:

X = Y [(A-B)/A]

where:

X = the number of Warrant Shares to be issued to the Holder.

 

Y = the number of Warrant Shares with respect to which this Warrant is being exercised.

 

A = the average of the daily volume weighted average price for the Common Stock for the five Trading Days immediately prior to (but not including) the Exercise Date.

 

B = the Exercise Price.

 

For purposes of Rule 144 promulgated under the Securities Act, it is intended, understood and acknowledged that the Warrant Shares issued in a cashless exercise transaction shall be deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date this Warrant was originally issued.

11.Limitations on Exercise. Notwithstanding anything to the contrary contained herein, the number of Warrant Shares that may be acquired by the Holder upon any exercise of this Warrant (or otherwise in respect hereof) shall be limited to the extent necessary to insure that, following such exercise (or other issuance), the total number of shares of Common Stock then beneficially owned by such Holder and its Affiliates and any other Persons whose beneficial ownership of Common Stock would be aggregated with the Holder's for purposes of Section 13(d) of the Exchange Act, does not exceed 9.99% of the total number of issued and outstanding shares of Common Stock (including for such purpose the shares of Common Stock issuable upon such exercise). For such purposes, beneficial ownership shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. This provision shall not restrict the number of shares of Common Stock which a Holder may receive or beneficially own in order to determine the amount of securities or other consideration that such Holder may receive in the event of a Fundamental Transaction as contemplated in Section 9 of this Warrant. This restriction may not be waived. Notwithstanding anything to the contrary contained in this Warrant, (a) no term of this Section may be waived by any party, nor amended such that the threshold percentage of ownership would be directly or indirectly increased, (b) this restriction runs with the Warrant and may not be modified or waived by any subsequent holder hereof and (c) any attempted waiver, modification or amendment of this Section will be void ab initio.

12.No Fractional Shares. No fractional Warrant Shares will be issued in connection with any exercise of this Warrant. In lieu of any fractional shares which would, otherwise be 

 

 

issuable, the Company shall pay cash equal to the product of such fraction multiplied by the closing price of one share of Common Stock as reported by the applicable Trading Market on the date of exercise, or round up to the nearest whole share of Common Stock.

13.Notices. Any and all notices or other communications or deliveries hereunder (including, without limitation, any Exercise Notice) shall be in writing and shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number specified in this Section prior to 6:30 p.m. (New York City time) on a Trading Day, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number specified in this Section on a day that is not a Trading Day or later than 6:30 p.m. (New York City time) on any Trading Day, (iii) the Trading Day following the date of mailing, if sent by nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given. The addresses for such communications shall be: (i) if to the Company, to Achieve Life Sciences, Inc., Attn: Chief Executive Officer, Facsimile No.: [] (or such other address as the Company shall indicate in writing in accordance with this Section), or (ii) if to the Holder, to the address or facsimile number appearing on the Warrant Register or such other address or facsimile number as the Holder may provide to the Company in accordance with this Section.

 

14.Warrant Agent. The Company shall serve as warrant agent under this Warrant. Upon 10 days' notice to the Holder, the Company may appoint a new warrant agent. Any corporation into which the Company or any new warrant agent may be merged or any corporation resulting from any consolidation to which the Company or any new warrant agent shall be a party or any corporation to which the Company or any new warrant agent transfers substantially all of its corporate trust or shareholders services business shall be a successor warrant agent under this Warrant without any further act.  Any such successor warrant agent shall promptly cause notice of its succession as warrant agent to be mailed (by first class mail, postage prepaid) to the Holder at the Holder's last address as shown on the Warrant Register.

15.Miscellaneous. 

 

(a)This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 5 except as expressly set forth in Section 9. Without limiting any rights of a Holder to receive Warrant Shares on a “cashless exercise” pursuant to Section 10(b) or to receive cash payments pursuant to Section 5(c) and 9(b), in no event shall the Company be required to net cash settle an exercise of this warrant.

 

(b)This Warrant shall be binding on and inure to the benefit of the parties hereto and their respective successors and assigns. Subject to the preceding sentence, nothing in this Warrant shall be construed to give to any Person other than the Company and the Holder any legal or equitable right, remedy or cause of action under this Warrant. This Warrant may be amended only in writing signed by the Company and the Holder and their successors and assigns. The foregoing sentence shall be subject to the restrictions on waivers and amendments set forth in Section 11 of this Warrant.

(c)All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance 

 

 

with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of this Warrant and the transactions herein contemplated ("Proceedings") (whether brought against a party hereto or its respective Affiliates, employees or agents) shall be commenced exclusively in the New York Courts. Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any Proceeding, any claim that it is not personally subject to the jurisdiction of any New York Court, or that such Proceeding has been commenced in an improper or inconvenient forum. Each party hereto hereby irrevocably waives personal service of process and consents to process being served in any such Proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Warrant or the transactions contemplated hereby. If either party shall commence a Proceeding to enforce any provisions of this Warrant, then the prevailing party in such Proceeding shall be reimbursed by the other party for its attorney's fees and other costs and expenses incurred with the investigation, preparation and prosecution of such Proceeding.

(d)The headings herein are for convenience only, do not constitute a part of this Warrant and shall not be deemed to limit or affect any of the provisions hereof.

(e)In case any one or more of the provisions of this Warrant shall be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Warrant shall not in any way be affected or impaired thereby and the parties will attempt in good faith to agree upon a valid and enforceable provision which shall be a commercially reasonable substitute therefor, and upon so agreeing, shall incorporate such substitute provision in this Warrant.

(f)Prior to exercise of this Warrant, the Holder hereof shall not, by reason of being a Holder, be entitled to any rights of a stockholder with respect to the Common Stock.

 

 

 

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be duly executed by its authorized officer as of the date first indicated above.

 

             ACHIEVE LIFE SCIENCES, INC.

By:__________________________

Name:

Title:

 

 

 

 

EXERCISE NOTICE

ACHIEVE LIFE SCIENCES, INC.

WARRANT 

DATED DECEMBER [  ], 2020

The undersigned Holder hereby irrevocably elects to purchase shares of Common Stock pursuant to the above referenced Warrant. Capitalized terms used herein and not otherwise defined have the respective meanings set forth in the Warrant.

	
 
	
(1)
	
The undersigned Holder hereby exercises its right to purchase 
	
 

__________ shares of Common Stock pursuant to the Warrant.

	
 
	
(2)
	
The holder shall pay the sum of $to the Company in accordance with the 
terms of the Warrant.

	
 
	
(3)
	
Pursuant to this Exercise Notice, the Company shall deliver to the holder Common Stock in accordance with the terms of the Warrant.

	
 
	
(4)
	
By its delivery of this Exercise Notice, the undersigned represents and warrants to the 
Company that in giving effect to the exercise evidenced hereby the Holder will not beneficially own in excess of the number of shares of Common Stock (determined in accordance with Section 13(d) of the Securities Exchange Act of 1934) permitted to be owned under Section 11 of the Warrant to which this notice relates.
	
 

				
	
Dated: 
	
Name of Holder:

(Print) 

By: 

Name: 

	
 
	
 

	
 
	
 
	
Title: 
	
 

	
 
	
 
	
(Signature must conform in all respects to name of holder as specified on the face of the Warrant)

 

 

 

Warrant Shares Exercise Log

				
	
Date
	
Number of Warrant Shares Available to be Exercised
	
Number of Warrant Shares Exercised
	
Number of Warrant Shares Remaining to be Exercised

	
 
	
 
	
 
	
 

 

 

 

ACHIEVE LIFE SCIENCES, INC.

REPRESENTATIVE’S COMMON STOCK PURCHASE WARRANT 

DATED DECEMBER [  ], 2020

WARRANT NO. 

FORM OF ASSIGNMENT

[To be completed and signed only upon transfer of Warrant]

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto

 the right represented by the above-captioned 

Warrant to purchase  shares of Common Stock to which such Warrant relates and appoints

attorney to transfer said right on the books of the Company with full power

of substitution in the premises.

Dated: 

(Signature must conform in all respects to name of holder as specified on the face of the Warrant)

Address of Transferee

In the presence of:

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