Document:

EX-10.12

EXHIBIT 10.12

	

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

4. REQUISITIONPURC N/A

2. AMENDMENT/MODIFICATION NO: Seven (7)

3. EFFECTIVE DATE See block 16C

PAGE OF PAGES 1 I 2

5. PROJECT NO. (If applicable! N/A
CODE

6. ISSUED BY

Btomedical Advanced Research and Development Authority U.S. Department of Health and Human Services
330 Independence Avenue, SW Room G640 Washington, DC 20201

7. ADMINISTERED BY [If other than item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Wo,, street, county. State and ZIP Code)

SioCryst Pharmaceuticals, Inc. 2190 Parkway Lake Drive
Birmingham, AL 35244 DUNS 61-819-4609 TIN 62-1413174

9A. AMENDMENT OF SOLICITATION NO,

9B. DATED {SEE ITEM 11)

CODE

FACILITY CODE

10A. MODIFICATION OF CONTRACT/ ORDER HHSO1002OO700032C

10B. DATED (SEE ITEM 13) 01-03-07

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

” The above numbered solicitation is amended as set forth in Item 14. The hour and date specified
for receipt of Offers “’ is extended, “ is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods: (a) By completing

Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this
amendment on sach copy of the offer submitted; or |c) By

separate letter or telegram which includes a reference to thB solicitation and amendment numbers.
FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS
PRIOR TO THE HOUR AND DATE SPECIFIED MAV RESULT IN REJECTION OF YOUR OFFER. If by virtue of this
amendment, you desire to change an offer already submitted, such change may be made by telegram or
letter, provided each telegram or letter makes reference to the solicitation and this amendment,
and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA {if required)

SOCC:. POC# TIN# LOC# CAN#

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS; IT MODIFIES THE CONTRACT/ORDER NO.
AS DESCRIBED IN ITEM 14.

A.

THIS CHANGE OROER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT
TO THE AUTHORITY OF FAR 43.1031b).

THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO
PURSUANT TO AUTHORITY OF: FAR 52.242-15 Stop-Work
Order; FAR 52.232-20 Limitation of Cost.

OTHER {Specify type of modification and authority]

E. IMPORTANT: Contractor (] is not, [X] is required to sign this document and return 2
copies to the issuing office.

1 4. DESCRIPTION OF MODIFICATION (Organized by UCF section headings, including
solicitation/contract subject matter where feasible]

PURPOSE: The purpose of this modification is to:

1. Cancel the Stop-Work Order issued on January 4, 2008, in accordance with FAR Clause
52,242-15, Stop Work Order.

2. Modify the contract as described on Page 2 of this modification.

The total contract amount remains unchanged. (4102,661,429)

The contract completion date remains unchanged. (December 31, 2010)

Except as provided herein, all terms and conditions referenced in item 9A or 10A, remain in full
force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
Schuyler T. Eldridge

15B. CONTRACTOR/OFFEROR
15C. DATE SIGNED
16C. DATE SIGNED

(Signature of person authorized to sign)
(Signature of Contracting Officer)

OMB No, 0990-0115
NSN 7540-01-152-8070

STANDARD FORM 30 [REV. 10-83)

 

 

HHSO100200700032C

Modification # 007

Page 2 of 2

	1.	 	The Stop Work Order issued on January 4, 2008, against this contract is hereby cancelled.
	 
	2.	 	The following activities will be completed, not exceeding the costs estimated in the BioCryst
Cost Proposal dated November 7, 2008, incorporated as an Attachment to this contract in
Section J.

	 	•	 	BARDA approves the proposed costs associated with clinical trial completion, including a
complete clinical study report, for the following studies:

	 	 	 	Clinical Trail Study BCX-1812-106
	 
	 	 	 	Clinical Trail Study BCX-1812-201
	 
	 	 	 	Clinical Trail Study BCX-1812-212

	 	•	 	Ongoing stability studies required for licensure of both the i.v. and i.m. formulations.
	 
	 	•	 	Any non-clinical toxicology or carcinogenicity studies that are ongoing and are required
for licensure of either formulation.

	3.	 	Milestone 3 Feasibility Plan listed on page 10 of the contract in Article F.3. Contract
Deliverables is due 60 days after the effective date of this Modification No. 7.
	 
	4.	 	All other activities listed in this contract and not referenced above shall be initiated only
after obtaining prior approval from the Contracting Officer in writing.
	 
	5.	 	The revised Contractor-defined Milestone Schedule and Gantt chart are incorporated as an
Attachment to this contract in Section J.
	 
	6.	 	The Key Personnel listed on page 12 of the contract in Article G.3. Key Personnel is removed
in its entirety and replaced with the following:

	 	 	 
	Name	 	Title
	William P. Sheridan, M.D.

	 	Chief Medical Officer, Principal Investigator
	Elliott Berger, Ph.D.

	 	Sr. Vice President, Regulatory Affairs
	Walter G. Gowan, Ph.D.

	 	Vice President — Chemistry, Manufacturing, and Control
	Phillip J. Collis, Ph.D.

	 	Executive Director of Clinical Development, Sub
Investigator
	Yahya El-Kattan, Ph.D.

	 	Director of Quality Control and Analytical Dept.
	Adele Jenne

	 	Director of Quality Assurance
	Amy McCullough, R.N., M.P.H.

	 	Director of Clinical Development

	7.	 	All other terms and conditions of this contract remain in full force and effect.EX-10.19

Exhibit 10.19

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

FIRST AMENDMENT

TO

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     This First Amendment (this “Amendment”) to the License, Development and Commercialization
Agreement between BioCryst Pharmaceuticals, Inc. (“BioCryst”) and Shionogi & Co., Ltd.
(“Shionogi”), dated as of February 28, 2007 (the “Agreement”), shall be effective as of September
30, 2008 (the “First Amendment Date”).

WITNESSETH

     WHEREAS, pursuant to Section 17.14 of the Agreement, the Agreement may be amended in writing
by BioCryst and Shionogi; and

     WHEREAS, BioCryst and Shionogi desire to amend the Agreement to expand the Territory to Taiwan
(defined below) and to provide rights for Shionogi to perform a Phase III Clinical Trial in Hong
Kong (defined below), which is outside the Territory.

     NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein and in
the Agreement, BioCryst and Shionogi, intending to be legally bound hereby, amend, update and
supplement the Agreement as follows:

1. Amendment of the Agreement. The parties hereby agree to amend the Agreement, effective
as of the First Amendment Date as follows:

	 	a.	 	Definitions. The following definitions shall be added to Section 1.1
of the Agreement, as follows:

          (fff) “Hong Kong” means the Hong Kong Special Administrative Region of the People’s Republic
of China.

          (ggg) “2008 Trial” means the Phase III Clinical Trial described in Section 5.1(a), below.

          (hhh) “Taiwan” means the territories of Taiwan, Republic of China.

	 	b.	 	Territory. Section 1.1(bbb) of the Agreement is hereby amended and
restated in its entirety as: ““Territory” means Japan and Taiwan”.
	 
	 	c.	 	References to Japan. The following references to “Japan” or “Japanese”
are hereby amended and restated in their entirety as follows:

          1(h) “cGMPs” means the United States then-current good manufacturing practices
and the equivalent standards of the Governmental Entities in the Territory.

 

 

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

          1(aa) “IND” means an Investigation of a New Drug Filing (or the Japanese or
Taiwanese equivalent) with a Regulatory Authority in the Territory for purposes
of obtaining permission to initiate human clinical testing in such jurisdiction.

          1(oo) “NDA” means a New Drug Application (or the Japanese or Taiwanese
equivalent), including all supplements and amendments thereto, for the approval
of the Licensed Product as a new drug by the MHLW or applicable Regulatory
Authority in the Territory.

	 	d.	 	Section 2.1. Section 2.1 is hereby amended and restated in its
entirety as:

          License Grant; Reservation of Rights; Right to Conduct 2008 Trial in Hong
Kong.

     (a) Solely to the extent necessary for Shionogi to perform its obligations
hereunder in accordance with the terms of this Agreement, and subject to all of
the rights retained hereunder, BioCryst hereby grants Shionogi a personal,
non-sublicensable, non-transferable, non-assignable right and license under the
BioCryst Patents and BioCryst Know-How, to (i) exclusively Develop Licensed
Products solely in the Field and in the Territory, and (ii) exclusively
Commercialize Licensed Products solely in the Field and in the Territory. The
foregoing license grant shall be deemed to extend to Shionogi’s Affiliate,
Taiwan Shionogi & CO., Ltd. (“Shionogi Taiwan”) solely with respect to
activities in Taiwan. Other than as explicitly set forth in this Section 2.1,
no other licenses to the BioCryst Intellectual Property Rights or otherwise
(including but not limited to all rights in BioCryst Intellectual Property
Rights outside the Field and outside the Territory) are granted in this
Agreement. ***.

     (b) In connection with the 2008 Trial, and only for such purpose, BioCryst
hereby grants Shionogi the limited, nonexclusive right to conduct the 2008 Trial
in Hong Kong. For the purposes of clarity, it is understood and agreed that the
foregoing right set forth in this Section 2.1(b) is granted in furtherance of
Shionogi’s rights in the Territory, is subject in all respects to all of the
terms and conditions set forth in this Agreement including the license grant and
retained rights, including in Sections 2.1(a) and 2.3, and does not include any
further rights to Develop or Commercialize in Hong Kong. All rights granted
under this Section 2.1(b) shall terminate upon the completion of the 2008 Trial.

	 	e.	 	Section 2.2. Section 2.2 is hereby amended and restated in its
entirety as:

          Manufacturing. ***.

	 	f.	 	Section 3.5(f). The following is hereby added as a new Section 3.5(f):

(f) BioCryst will be obligated to supply Licensed Product and Compound to
Shionogi pursuant to this Section 3.5 (and otherwise under this Agreement) only
in Japan, and not in any other location, including Taiwan, unless otherwise
agreed to in writing by the Parties.

	 	g.	 	Section 3.6. The following is hereby added to the end of Section 3.6:

2

 

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

BioCryst will be obligated to supply Compound to Shionogi pursuant to this
Section 3.6 (and otherwise under this Agreement) only in Japan, and not in any
other location, including Taiwan, unless otherwise agreed to in writing by the
Parties.

	 	h.	 	Section 5.1. The following is hereby added at the end of the existing
Section 5.1:

Shionogi hereby acknowledges and agrees that, notwithstanding the fact that the
Territory includes the jurisdictions of Japan and Taiwan, Shionogi shall give
priority to its Development activities and achievement of the Milestone Events
set forth in Section 5.6 in Japan over Taiwan.

	 	i.	 	Section 5.1(a). The following is hereby added as a new Section 5.1(a)
of the Agreement:

5.1(a) 2008 Trial Diligence. Shionogi hereby agrees to use Diligent
Efforts to undertake and complete the 2008 Trial in accordance with the criteria
and time frames set forth on Schedule 5.1(a), solely at Shionogi’s cost and
expense.

	 	j.	 	Section 5.2. Section 5.2 is hereby amended and restated in its
entirety as:

Product Development outside the Territory. Other than as expressly set
forth in Section 2.1(b) and solely with respect to Hong Kong, BioCryst shall
have sole decision-making authority with regard to the Development and
Commercialization of Licensed Products outside the Territory (and no rights
under this Agreement are granted to Shionogi outside the Territory).

	 	k.	 	Section 6.6. The following is herby added to the end of the existing
Section 6.6 of the Agreement:

In no event may Shionogi or any Affiliate of Shionogi directly or indirectly
register, or attempt to register, or assert any rights to any party in respect
of any translation of a trademark, domain name or trade name owned by BioCryst.

	 	l.	 	Section 9.3. The preamble of Section 9.3 is herby amended and restated
in its entirety as:

Royalty Payments. In partial consideration for the licenses and rights
granted to Shionogi under this Agreement, Shionogi shall pay to BioCryst the
following royalty payments, on a country-by-country basis within the Territory
(pursuant to the currency and exchange provisions set forth in Section 9.6
herein and the taxes provision in Section 9.7 herein), as calculated based on
Net Sales in Japanese Yen, regardless of the country of sale (as converted,
where applicable), which shall be paid within *** the end of each calendar
quarter:

	 	m.	 	Section 9.3(c). Section 9.3(c) is hereby amended and restated in its entirety
as:

Term. The term for the obligations to pay royalties under this Section
9.3 shall expire on a country-by-country basis within the Territory on the date
that is the later of (i) *** and (ii) ***. If the royalty obligations in this
Section 9.3(c) are prohibited by applicable Law, then the royalty obligations
shall continue until such time as the obligation is prohibited by applicable
Law.

	 	n.	 	Section 9.3(d). Section 9.3(d) is hereby amended and restated in its entirety
as:

3

 

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

Patent Coverage Adjustment. If there is no Valid Claim that, but for
this Agreement would be infringed by the manufacture, use or sale of Licensed
Product in either Japan or Taiwan, then the royalty obligations from Shionogi to
BioCryst shall be reduced by ***. If there is a Valid Claim in Japan, and if

(i)

	 	***	 	          , then ***; OR

(ii)

	 	***	 	          , then ***

          Where:

	 	•	 	GPS = the number of units of Generic Products sold in Japan for a
given period, and
	 
	 	•	 	LPS = the number of units of Licensed Products sold in Japan for a
given period.

For purposes of this Section 9.3(d) the number of “units” sold shall be
appropriately adjusted to account for units of varying volumes.

	 	o.	 	Section 9.3(f). Section 9.3(f) is hereby amended and restated in its entirety
as:

Royalty Reports. All royalty payments shall be accompanied by written
reports from Shionogi to BioCryst, showing for the calendar quarter for which
such payment applies, in U.S. Dollars, all information required by BioCryst to
verify the royalty payments payable hereunder, including but not limited to the
information set forth on Schedule 9.3(f) for each country within the Territory,
and any other information customary with industry standards of the Territory.

	 	p.	 	Section 10.1. The references to “the Territory” in Section 10.1 are
hereby changed to “Japan”.

2. Shionogi Taiwan. Shionogi hereby guarantees the obligations of Shionogi Taiwan and
agrees to ensure that Shionogi Taiwan complies with each and every one of Shionogi’s obligations
under the Agreement.

3. No Other Changes. Except as expressly modified by this Amendment, all terms and
conditions of the Agreement shall remain in full force and effect.

4. Interpretation of Certain Terms. All terms which are capitalized but not defined in
this Amendment shall have the meanings ascribed in the Agreement. The words “this Agreement,”
“hereunder,” “hereof” and other similar words in the Agreement from and after the First Amendment
Date shall mean and include the Agreement as amended hereby.

5. Governing Law; Venue. This Amendment shall be governed by and construed and enforced in
accordance with the laws of the State of New York without regard to choice-of-law principles of the State

4

 

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

of New York. All actions
arising under this Amendment which are not arbitrable shall be brought in the State and Federal
Courts located in New York County, New York. The Parties hereby irrevocably submit to the
jurisdiction of such courts.

6. Counterparts. This Amendment may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument.

     IN WITNESS WHEREOF, the undersigned have duly executed this Amendment as a sealed instrument
by and through their duly authorized representatives.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	BIOCRYST PHARMACEUTICALS, INC.

2190 Parkway Lake Drive

Birmingham, Alabama 35244

United States	 	 	 	
Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome

Chuo-ku, Osaka 541-0045

Japan 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:	 	/s/ David McCullough	 	 	 	By:	 	/s/ Takuko Yamada Sawada	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Name:

Title:
	 	David McCullough

VP Corp. Dev., Strategy, Commercial
	 	 	 	 	 	Name:

Title:
	 	Takuko Yamada Sawada

Corporate Officer, Executive General

 Manager, Pharmaceutical Development Div.
	 	 
	 
	Date:	 	 October 15, 2008	 	 	 	Date:	 	 October 3, 2008	 	 

5

 

Pursuant to 17 CFR 240.24b-2, confidential information has been omitted in places marked “* * *”
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.

SCHEDULE 5.1(a)

PHASE III CLINICAL TRIAL DESCRIPTION

The Phase III trial which Shionogi plans to conduct in the 2008/2009 flu season and use for
registration in the Territory for the purpose of receiving Marketing Approval from the Regulatory
Authorities in the Territory for the treatment of seasonal flu. The formulation in this Phase III
study will be administered intravenously.

6

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