Document:

exv10w2

 

Exhibit 10.2

BIOCRYST PHARMACEUTICALS, INC.

2190 PARKWAY LAKE DRIVE

BIRMINGHAM, AL 35244

205-444-4600 205-444-4640 FAX

www.biocryst.com

June 19, 2006

William James Alexander, M.D.

307 Whisperwood Dr.

Cary, North Carolina 27511

Dear Jim:

This letter agreement (the “Agreement”) will serve to confirm our agreement with respect to
the terms and conditions of your employment by BioCryst Pharmaceuticals, Inc., a Delaware
corporation (“BioCryst” or the “Company”).

The terms and conditions of your employment are as follows:

1. Term of Employment. Subject to the terms and conditions of this Agreement, BioCryst
hereby employs William James Alexander (“you” or “employee”), and you hereby accept such employment
commencing on or about June 19, 2006 hereof. You shall be employed to serve as BioCryst’s Senior
Vice President, Clinical and Regulatory Operations, and Chief Medical Officer and you shall report
to Claude Bennett, the President and Chief Operating Officer of BioCryst. You shall devote your
full business time and energies to the Company, and shall not engage in any other business activity
that would interfere with, or prevent you from carrying out, your duties and responsibilities under
this Agreement. You will be considered an executive officer of the Company subject to the
provisions of Section 16 of the Securities Exchange Act of 1934 relating to insider trading.

2. Basic Full-Time Compensation and Benefits.

(a) (i) As base salary for services rendered under this Agreement, you shall be entitled to
receive from BioCryst, for the term of your full-time employment under this Agreement, an aggregate
base salary of $320,000 per year, which remuneration shall be payable in equal semi-monthly
installments on the 15th and last business days of each month during the term of this
Agreement. This base salary will be reviewed annually by the Compensation Committee (“the
Committee”) of the Board of Directors and may be raised at the discretion of the Committee.

(ii) In addition to the base salary set forth in (i) above, you will receive a signing bonus
of $45,000 upon joining BioCryst, and a minimum 2006 bonus of $45,000, payable as part of our
normal compensation cycle in late 2006 or early 2007. Beginning in 2007, you shall also be
eligible for an annual incentive bonus of up to 40% of your annual salary, with the amount of such
bonus to be determined by the Committee in its sole discretion. The annual incentive bonus will be
payable as a combination of cash and stock options (which options, if issued in payment of any
portion of the annual incentive bonus, will be valued using the methodology then utilized by the
Company to value stock options at the time of issuance), and will be payable in accordance with the
Company’s normal procedures and payment dates for annual incentive bonuses of executive officers.

 

 

 

(b) In addition to the compensation set forth in (a) above, you shall be entitled to receive
such other benefits and perquisites provided to other executive officers of BioCryst which benefits
may include, without limitation, reasonable vacation, sick leave, medical and dental benefits, life
and disability insurance, and participation in profit sharing or retirement plans.

3. Stock Options.

(a) The Company will grant you an option (the “Option”) to acquire 300,000 shares of the
Company’s common stock at a price determined based on the price of the Company’s common stock on
your first day of work. The Option will be granted under the Company’s existing stock option plan
for employees and, except to the extent otherwise provided in this Agreement, shall be subject to
the terms and provisions thereof.

(b) The parties intend for the Option to qualify as “incentive stock options,” as that term is
defined in Section 422 of the Internal Revenue Code of 1986, as amended (“Section 422”) to the
fullest extent possible. The parties understand that the portion of the Option, together with the
portion of any other incentive stock option granted by BioCryst and its parent and subsidiary
corporations, if any, which may become exercisable in any year in excess of an aggregate of
$100,000 fair market value, determined as of the date the Option or such other option, as the case
may be, was granted, may not be treated as an incentive stock option under Section 422.

(c) The Option may be exercised and the common stock to be purchased pursuant thereto may be
purchased by you as a result of such exercise only within the periods allowed under and otherwise
in accordance with the Company’s policies regarding trading in its securities by employees and
executive officers.

(d) The Option shall be 25% exercisable one year after the date it is granted, and the
remaining seventy-five percent (75%) shall vest and become exercisable at the rate of 1/48th per
month, commencing with the thirteenth (13th) month after the date such Option is granted, and
continuing to vest for the succeeding months until fully vested and exercisable.

(e) In no event shall the period for exercising the Option exceed ten (10) years from the date
the Option is granted.

4. Travel Expenses. Your initial home base will be in North Carolina, and BioCryst will
reimburse you for your travel costs and accommodations expenses for your trips to Birmingham while
you are based in North Carolina.

5. Relocation Expenses. The company shall pay all relocation expenses, including any
necessary tax gross up, for any relocation to the Birmingham, Alabama metropolitan area that are
incurred by you within nine months from the date of your employment, not to exceed $50,000 in the
aggregate.

6. Termination. Your employment under this Agreement is considered “at will”. In addition,
you may be terminated in the following circumstances:

(a) The Company may terminate your employment hereunder immediately for “Cause” and without
payment of any further amounts hereunder. “Cause” for termination of your employment hereunder
shall exist if you

(i) shall confess to committing or shall be convicted of any felony or any crime
involving moral turpitude, or

(ii) shall have engaged in gross and willful misconduct which is materially injurious
to the business of the Company, or

(iii) you materially breach any provisions of this Agreement, which breach is not cured
within thirty (30) days after notice of such breach has been given by the Company to you.

(b) The Company may terminate your employment hereunder upon thirty (30) days written notice
if you shall have suffered a period of permanent disability, which shall for purposes of this
Agreement be defined as your inability to perform your duties hereunder by reason of physical or
mental incapacity for ninety (90) days, whether consecutive or not, during any consecutive twelve
(12) month period.

 

 

 

(c) This Agreement and your employment hereunder will automatically terminate upon your death.

Upon termination of your employment in accordance with this paragraph 6, all of your rights to
receive any future payments under paragraph 2 above, except for amounts accrued through the date of
termination, shall cease.

7. Confidentiality.

(a) Confidentiality. Except as the Company may otherwise consent in writing, or
except as may be required by a court of competent jurisdiction or by proceedings therein, you shall
not publish or otherwise disclose, disseminate or (other than for the benefit of the Company) make
use of either during or subsequent to the time period of this Agreement, any information, knowledge
or data of the Company or of its subsidiaries or affiliated companies or of its customers relating
to customer lists, devices, techniques, plans, methods, trade secrets, know-how, inventions,
discoveries, formulas, processes, machines and the selection, utilization and maintenance thereof,
compositions, or business or financial plans or reports, or other matters which are of a secret or
confidential nature. For purposes of this Agreement the terms “secret” and “confidential” are used
in the ordinary sense and do not refer to official security classifications of any government or
any agency thereof.

(b) Equitable Remedies. You acknowledge and recognize that a violation of this
paragraph 7 by you may cause irreparable and substantial damage and harm to BioCryst or its
affiliates, could constitute a failure of consideration, and that money damages will not provide a
full remedy for BioCryst for such violations. You agree that in the event of his breach of this
paragraph, BioCryst will be entitled, if it so elects, to institute and prosecute proceedings at
law or in equity to obtain damages with respect to such breach, to enforce the specific performance
of this paragraph by you, and to enjoin you from engaging in any activity in violation hereof.

8. Company Policies. Except as expressly set forth in this Agreement, your employment will
be subject to all policies and procedures to which employees of the Company are generally subject.

9. Miscellaneous.

(a) Entire Agreement. This Agreement, including the exhibits hereto, constitutes the
entire agreement between the parties relating to your employment by BioCryst and there are no terms
relating to such employment other than those contained in this Agreement. No modification or
variation hereof shall be deemed valid unless in writing and signed by the parties hereto. No
waiver by either party of any provision or condition of this Agreement shall be deemed a waiver of
similar or dissimilar provisions or conditions at any time.

(b) Notices. Any notice or other communication given or rendered hereunder by any
party hereto shall be in writing and delivered personally or sent by registered or certified mail,
postage prepaid, at the respective addresses of the parties hereto as set forth below.

(c) Captions. The section headings contained herein are inserted only as a matter of
convenience and reference and in no way define, limit or describe the scope of this Agreement or
the intent of any provision hereof.

(d) Taxes. All amounts to be paid to you hereunder are in the nature of compensation
for your employment by BioCryst, and shall be subject to withholding, income, occupation and
payroll taxes and other charges applicable to such compensation.

(e) Governing Law. This Agreement is made and shall be governed by and construed in
accordance with the laws of the State of Alabama without respect to its conflicts of law
principles.

If the foregoing correctly sets forth our understanding, please signify your acceptance of
such terms by executing this Agreement, thereby signifying your assent, as indicated below.

 

 

 

	 	 	 
	 

	 	Yours very truly,
	 
	 	 
	 

	 	BIOCRYST PHARMACEUTICALS, INC.
	 
	 	 
	 

	 	By:/s/ Charles E. Bugg
	 
	 	 
	 

	 	Charles E. Bugg
	 

	 	Its Chairman & Chief Executive Officer

AGREED AND ACCEPTED as of this 19th day of June, 2006.

/s/ William James Alexanderexv10w4

 

Exhibit 10.4

 

NOTE: THIS DOCUMENT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST PURSUANT TO RULE 24B-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934. PORTIONS OF THIS DOCUMENT FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED HAVE BEEN REDACTED AND ARE MARKED HEREIN BY “***”. SUCH REDACTED
INFORMATION HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO THE CONFIDENTIAL TREATMENT
REQUEST.

 

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

by and between

BIOCRYST PHARMACEUTICALS, INC.

and

SHIONOGI & CO., LTD.

Dated as of February 28, 2007

 

 

 

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Agreement”) is entered into
as of February 28, 2007 by and between BIOCRYST PHARMACEUTICALS, INC., a corporation organized and
existing under the laws of the State of Delaware having offices at 2190 Parkway Lake Drive,
Birmingham, Alabama 35244 (“BioCryst”), and SHIONOGI & CO., LTD., a corporation organized and
existing under the laws of the Japan having offices at 1-8, Doshomachi 3-chome, Chuo-ku, Osaka
541-0045, Japan (“Shionogi”). BioCryst and Shionogi are each referred to herein by name or
individually as a “Party” or collectively as the “Parties.”

BACKGROUND

WHEREAS, BioCryst owns or controls patents, know-how and other intellectual property related
to a compound known as Peramivir.

WHEREAS, Shionogi has expertise in the discovery, development, manufacture and sale of
pharmaceutical products in the Territory (as defined below).

WHEREAS, Shionogi wishes to obtain, and BioCryst wishes to grant, in the Territory only,
rights and licenses under certain of BioCryst’s patents, know-how and trademarks to Shionogi so
that Shionogi can obtain the necessary regulatory approvals to sell Licensed Products (as defined
below) in the Territory.

NOW, THEREFORE, in consideration of the premises and mutual covenants herein below, and for
other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

1.1 Defined Terms. As used in this Agreement, the following terms shall have the meanings
indicated:

(a) "Affiliate” means any corporation or other entity which is directly or indirectly
controlling, controlled by or under common control of a Party, for so long as such control exists.
For the purposes of this Section 1.1(a), “control” means direct or indirect ownership of fifty
percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest
permitted by applicable Law) of the voting rights, shares or other equity or income interest of a
Party.

(b) "BioCryst Know-How” means Know-How owned, developed or controlled by, or licensed to,
BioCryst.

 

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(c) "BioCryst Intellectual Property Rights” means all Intellectual Property Rights owned or
controlled by BioCryst, including but not limited to BioCryst Know-How, the BioCryst Marks, and
BioCryst Patents.

(d) "BioCryst Logo” means the company logo of BioCryst in a form provided, and approved in
writing, by BioCryst from time to time.

(e) "BioCryst Marks” means the BioCryst Logo and any trademark, trade name or logo approved by
BioCryst for use in connection with the Commercialization of the Licensed Product (whether or not
owned by BioCryst).

(f) "BioCryst Patents” means those Patents owned, licensed or controlled by BioCryst which are
filed in the Territory and which relate to the manufacture, use or sale of Licensed Products and/or
Compound, which are set forth on Schedule 1.1(f).

(g) "Budget” means, individually, the applicable budget set forth in the Development Plan or
Commercialization plan.

(h) "cGMPs” means the United States then-current good manufacturing practices and the
equivalent standards of the Japanese government.

(i) "Change of Control” means, with respect to a Party, any of the following events: (i) any
corporation or other entity is or becomes the “beneficial owner” (as such term is used in sections
12(d) and 13(d) of the Securities Exchange Act of 1934, as amended, except that a corporation or
other entity shall be deemed to have “beneficial ownership” of all shares that any such corporation
or other entity has the right to acquire, whether such right may be exercised immediately or only
after the passage of time), of a majority of the total voting power represented by all classes of
capital stock then outstanding of such Party normally entitled to vote in elections of directors of
the Party; (ii) such Party consolidates with or merges into another corporation or entity, or any
corporation or entity consolidates with or merges into such Party, other than (A) a merger or
consolidation which would result in the voting securities of such Party outstanding immediately
prior to such merger or consolidation continuing to represent (either by remaining outstanding or
by being converted into voting securities of the surviving entity or any parent thereof) a majority
of the combined voting power of the voting securities of such Party or such surviving entity or any
parent thereof outstanding immediately after such merger or consolidation, or (B) a merger or
consolidation effected to implement a recapitalization of such Party (or similar transaction) in
which no corporation or other entity becomes the beneficial owner, directly or indirectly, of
voting securities of such Party representing a majority of the combined voting power of such
Party’s then outstanding securities; or (iii) such Party conveys, transfers or leases all or
substantially all of its assets to any corporation or other entity other than a wholly-owned
subsidiary of such Party in one or more related transactions.

(j) “COGS” or “Cost of Goods Sold” means, ***.

(k) “Combination Product” means ***.

 

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(l) "Commercialization” means, with respect to Licensed Product, any and all processes and
activities conducted to establish and maintain sales for such Licensed Product, including offering
for sale, detailing, selling (including launch), marketing (including education and advertising
activities), promoting, manufacturing Licensed Product from Compound, but not manufacturing
Compound itself), storing, transporting, supporting, distributing, and importing such product, but
shall exclude development and manufacturing of Compound. “Commercialize” and “Commercializing”
shall have their correlative meanings.

(m) "Compound” means the chemical compound known as “Peramivir” having the following chemical
structure:

(1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]
-4-[(aminoiminomethyl)amino]-2-hydroxy-cyclopentanecarboxylic acid, trihydrate

including the salts, esters, prodrugs, metabolites, tautomers, isomers, labeled compounds,
conjugates, complexes, and other related compounds thereof.

(n) "Data” means any and all research, pharmacology, medicinal chemistry, chemistry,
manufacturing and controls, nonclinical, clinical and other data (including investigator reports
and clinical study reports (both preliminary and final), statistical analyses, expert opinions and
reports, safety and other electronic databases), in each case specifically directed to, or used in
the Development and Commercialization of, a Licensed Product and/or Compound.

(o) "Development” means, with respect to a Licensed Product, any and all processes and
activities conducted to obtain Marketing Approvals for such product, including IND Enabling Studies
and all other activities conducted thereafter, which may involve nonclinical studies, studies of
chemistry, manufacturing and controls, clinical trials, quality of life assessments,
pharmacoeconomics, post-marketing studies, label expansion studies, and further activities related
to development of such product to a stage ready for Commercialization thereof. “Develop” and
“Developing” shall have their correlative meanings.

(p) "Development Costs” means all costs and expenses to be incurred by a Party in the course
of the Development of Licensed Product, including, but not limited, to the costs of conducting
clinical trials, regulatory filing and maintenance fees, pricing and reimbursement filing and
maintenance fees and costs relating to approval by the Regulatory Authority of the Licensed
Product.

(q) "Development Plan” means the development plan pursuant to which Shionogi shall Develop the
Licensed Product, which shall be prepared by the JSC within forty-five (45) days after the
Effective Date, attached to this Agreement as Schedule 1.1(q) and made a
part of this Agreement, and which may be modified at anytime, and from time to time by the
JSC.

 

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(r) “Diligent Efforts” means, ***.

(s) “Effective Date” means the date hereof.

(t) "FDA” means the United States Food and Drug Administration, or any successor entity
thereto.

(u) "Field” means the prevention and/or treatment of all forms of influenza, in humans
(including avian influenza) .

(v) "GAAP” means then-current generally accepted accounting principles in the United States as
established by the Financial Accounting Standards Board or any successor entity or other entity
generally recognized as having the right to establish such principles, in each case consistently
applied.

(w) “Generic Product” means ***.

(x) "GLP” means the then-current good laboratory practice (or similar standards) for the
performance of laboratory activities for pharmaceutical products as are required by any Regulatory
Authority in the applicable jurisdiction.

(y) “Governmental Entity” means ***.

(z) "Guiding Principle” means in the timely Development of Licensed Products.

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

(bb) "IND Enabling Studies” means studies which in each case are reasonably necessary to
obtain approval of an IND, including GLP, ADME (absorption, distribution, metabolism and
excretion), toxicology, pharmacology and safety pharmacology studies, or studies of chemistry,
manufacturing and controls.

(cc) "Initiation” means, with respect to a particular clinical trial, the date of enrollment
of the first subject or patient in such trial.

(dd) "Insolvency Event” means, with respect to any Party, the occurrence of any of the
following: (i) such Party shall commence a voluntary case concerning itself under any bankruptcy,
liquidation or insolvency code; (ii) an involuntary case is commenced against such Party under any
bankruptcy, liquidation or insolvency code and the petition is not controverted within ten (10)
business days, or is not dismissed within sixty (60) days, after commencement of the case; (iii) a
custodian is appointed for, or takes charge of, all or substantially all of the property of such
Party or such Party commences any other proceedings under any

 

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reorganization, arrangement, adjustment of debt, relief of debtors, dissolution, insolvency or
liquidation or similar law of any jurisdiction whether now or hereafter in effect relating to such
Party or there is commenced against such Party any such proceeding which remains undismissed for a
period of sixty (60) days; (iv) any order of relief or other order approving any such case or
proceeding is entered; (v) such Party is adjudicated insolvent or bankrupt; (vi) such Party suffers
any appointment of any custodian, receiver or the like for it or any substantial part of its
property to continue undischarged or unstayed for a period of sixty (60) days; (vii) such Party
makes a general assignment for the benefit of creditors; (viii) such Party shall be unable to pay,
its debts generally as they become due; (ix) such party shall call a meeting of its creditors with
a view to arranging a compromise or adjustment of its debts; (x) such Party shall by any act or
failure to act consent to, approve of or acquiesce in any of the foregoing; or (xi) any corporate,
limited liability company, partnership or individual action, as applicable, is taken by such Party
for the purpose of effecting any of the foregoing.

(ee) "Intellectual Property Rights” shall mean all Patent, copyright, trade secret, trademark
and other proprietary and intellectual property rights, anywhere in the world.

(ff) “Japan” means the country of Japan.

(gg) “JSC” or “Joint Steering Committee” shall have the meaning set forth in Section 4.1.

(hh) "Know-How” means all scientific and technical information and know-how, trade secrets,
Data and technology now or hereafter during the term of this Agreement (whether patented,
patentable or not) owned, developed or acquired by a Party or any of its Affiliates or as to which
such Party or any of its Affiliates has the right to license (without a payment obligation to any
third party), which relates to the Licensed Product and/or Compound, including but not limited to
(a) medical, clinical, toxicological or other scientific Data; and (b) processes and analytical
methodology useful in the development, testing, formulation, analysis or packaging (but not
manufacturing of Compound) of the Licensed Product and/or Compound.

(ii) "Law” means, individually and collectively, any and all laws, ordinances, rules,
directives and regulations of any kind whatsoever of any governmental or regulatory authority
within the applicable jurisdiction.

(jj) “Licensed Product” means ***.

(kk) "Marketing Approval” means, with respect to a particular product in a particular
jurisdiction, all approvals, licenses, registrations or authorizations necessary for the
Commercialization of such product in such jurisdiction. Marketing Approval shall be deemed to have
been received upon first receipt by a Party or its designee of notice from the applicable
Regulatory Authority that Commercialization of such product has been approved in such jurisdiction.

(ll) “Marketing Approval Application” or “MAA” means a filing with the applicable Regulatory
Authority for purposes of obtaining Marketing Approval in a particular jurisdiction.

 

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(mm) “Material Use” means ***.

(nn) "MHLW” means the Ministry of Health, Labour and Welfare of Japan or any successor entity
thereto.

(oo) "NDA” means a New Drug Application (or the Japanese 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.

(pp) “Net Sales” means, ***.

(qq) "Patent” means any of the following, whether existing now or in the future anywhere in
the world: (a) patents and patent applications; (b) continuations, continuations-in-part,
divisionals and substitute applications with respect to any such patent application; (c) any
patents issued based on or claiming priority to any such patent applications; (d) any reissue,
reexamination, renewal or extension (including any supplemental patent certificate) of any such
patents; and (e) any confirmation patent or registration patent or patent of addition based on any
such patents.

(rr) "Phase I Clinical Trial” means a clinical trial of Licensed Product including small scale
clinical trial in human subjects to obtain information on such Licensed Product’s safety,
tolerability, pharmacological activity, pharmacokinetics and/or pharmacodynamics, and supporting
Marketing Approval of such Licensed Product in the Field, as more fully defined in 21 CFR 312.21(a)
or the equivalent statute or regulation in the Territory.

(ss) "Phase II Clinical Trial” means a well-controlled clinical trial of Licensed Product in
patients, a principal purpose of which is to make a preliminary determination that such Licensed
Product is safe for its intended use and to obtain sufficient information about such Licensed
Product’s safety, as well as to obtain an indication of the dosage regimen required, to permit the
design of further clinical studies, and supporting Marketing Approval of such Licensed Product in
the Field, as more fully defined in 21 CFR 312.21(b) or the equivalent statute or regulation in the
Territory.

(tt) "Phase III Clinical Trial” means a large scale clinical trial conducted in a sufficient
number of patients that is designed to establish that the Licensed Product is safe and efficacious
for its intended use, and to obtain warnings, precautions and adverse reactions that are associated
with such Licensed Product in the dosage range to be prescribed, and supporting Marketing Approval
of such Licensed Product in the Field, as more fully defined in 21 CFR 312.21(c) or the equivalent
statute or regulation in the Territory.

(uu) “Plans” means, collectively, the Development Plan and the Commercialization Plan.

(vv) "Pre-Existing Third Party License” means the agreement dated as of November 23, 1994 by
and between, on the one hand The UAB Research Foundation (“UAB”), and on the other hand BioCryst,
as amended and may be amended from time to time.

 

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(ww) "Promotional Material” means all Licensed Product packaging and labeling, and all
written, printed, graphic, electronic, audio or video matter, including journal advertisements,
sales visual aids, leave behind items, formulary binders, reprints, direct mail, direct-to consumer
advertising, Internet postings, broadcast advertisements and sales reminder aids (for example,
scratch pads, pens and other like items), in each case created by a Party or on its behalf and used
or intended for use in connection with any promotion of a Licensed Product in the Territory.

(xx) "Regulatory Authority” means any federal, national, multinational, state, provincial or
local regulatory agency, department, bureau or other governmental entity with authority over the
Development, Commercialization or other use (including the granting of Marketing Approvals) of any
Licensed Product in any jurisdiction, including the FDA, the MHLW and the Pharmaceuticals and
Medical Devices Agency.

(yy) "Regulatory Filings” means all submissions, applications, filings and approvals by, with
or from any Regulatory Authority.

(zz) "Sale”, “Sold” or “Sell” shall mean the sale, transfer or disposition of a Licensed
Product for commercial or clinical purposes as provided in this Agreement, for value to a Third
Party (whether an end user, wholesaler or otherwise) by Shionogi or any of its Affiliates.

(aaa) “Shionogi Know-How” means all Know-How owned, developed or acquired by or on behalf of
Shionogi and its Affiliates.

(bbb) “Territory” means Japan.

(ccc) "Third Party” means any entity other than Shionogi or BioCryst, or their respective
Affiliates.

(ddd) “U.S. Government” shall mean the federal government of the United States of America and
any of its branches and instrumentalities, including its departments, agencies, bureaus,
commissions, boards, courts, corporations, offices, and other entities, and any divisions or units
thereof.

(eee) “Valid Claim” means a claim in any unexpired and issued BioCryst Patent that has not
been revoked or held invalid by a final unappealable decision of a court or governmental agency of
competent jurisdiction.

ARTICLE 2

LICENSE GRANT, RETAINED RIGHTS AND PROVISION OF DATA

2.1 License Grant; Reservation of Rights. 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

 

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Territory, and (ii) exclusively Commercialize Licensed Products solely in the Field and in the
Territory. 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. ***

2.2 Manufacturing. ***.

2.3 Retained Rights; Government Rights. All rights granted to Shionogi hereunder are
subject to rights reserved by and/or granted to UAB or the U. S. Government. Shionogi specifically
understands and agrees that BioCryst shall have the unrestricted and fully unfettered right under
the BioCryst Intellectual Property Rights outside of the Field in the Territory and outside of the
Territory in the Field, including in connection with the testing, Development, manufacture and
Commercialization of products covered by the BioCryst Patents and BioCryst Know-How.

2.4 BioCryst Logo. BioCryst hereby grants to Shionogi a personal, non-sublicensable,
non-transferable, non-assignable right and license to use the BioCryst Logo on Licensed Products in
the Field in the Territory in accordance with the terms of this Agreement. Shionogi agrees to mark
(i) all packaging, labeling and package inserts for Licensed Product and (ii) such Promotional
Material as shall be agreed upon by the Parties in writing, with the BioCryst Logo. All use of the
BioCryst Logos shall be as directed by BioCryst and shall be in a form, style and prominence as
directed by BioCryst, and all goodwill associated with the use of the BioCryst Logos shall inure to
BioCryst.

2.5 Transfer of Data.

(a) BioCryst Existing Data. BioCryst shall transfer to Shionogi, *** after the
Effective Date, all Data (to the extent contractually permissible) possessed or controlled by
BioCryst as of the Effective Date, including, but not limited to ***. Certain Data (including
the Future Data described below) specified by Shionogi shall be accompanied by a statement or
certificate by an employee or agent of BioCryst in such form as mutually agreed upon by the
Parties. Shionogi acknowledges and agrees that delivery of Data in electronic form shall be
acceptable. BioCryst represents and warrants that, to its best knowledge, all studies, testings
and clinical trials from which the Data were derived were conducted in accordance with
then-applicable United States Laws.

(b) Shionogi Nonclinical Data and Phase I Data. Shionogi will promptly, *** disclose
to BioCryst all nonclinical Data and Data from Phase I Clinical Trials (whether or not such Data
meets the criteria of “Future Data”, set forth below in Section 2.5(c)(i)) developed by or on
behalf of Shionogi or which otherwise comes into Shionogi’s possession or control after the
Effective Date.

(c) Future Data.

(i) Data Exchange. From time to time (including upon request by either Party)
during the Term of this Agreement, each Party shall, ***, disclose to the other Party all
previously undisclosed Data relating to the Licensed Product and/or Compound
that (i) comes into such Party’s possession or control after the Effective Date and (ii) is
necessary to obtain or maintain a Marketing Approval for a Licensed Product (“Future Data”).
***.

 

-8-

 

(ii) Material Use. ***.

(d) Raw Data. A Party generating the Data subject to exchange under Section 2.5(a)
and (c)(ii) shall keep all of raw data from which the Data were derived in commercially usable
condition in accordance with applicable Laws and shall allow the other Party access to such raw
data upon the reasonable request by the other Party.

ARTICLE 3

COMMERCIAL MATTERS

3.1 General. Shionogi shall use Diligent Efforts to Develop Licensed Products in the
Field in the Territory, including any IND, MAA, Marketing Approval and any approval for any product
labeling or Promotional Materials and to maintain all such Regulatory Filings; and unless otherwise
agreed or required by applicable Laws, all such approvals shall be owned by and be held in the name
of Shionogi or its Affiliates. BioCryst shall cooperate with Shionogi in preparing all Regulatory
Filings and correspondence with Regulatory Authorities in the Territory. Shionogi shall use
Diligent Efforts to Commercialize the Licensed Products in the Territory. Notwithstanding the
foregoing covenant to cooperate, the Parties acknowledge and agree that all responsibility for
Regulatory Filings and exercising Diligent Efforts in the Territory shall be Shionogi’s.

3.2 BioCryst’s Participation.

(a) Protocols. Shionogi shall pay due consideration to the protocols and desired
endpoints in the trials sponsored by BioCryst in preparing the protocols for the clinical trials to
be conducted by or on behalf of Shionogi in the Territory. Shionogi shall provide BioCryst with the
outline of the draft of protocols (in the English language) for clinical trials. Consistent with
applicable Laws, Shionogi shall afford BioCryst an opportunity to comment on such protocols within
fifteen (15) business days after receipt and shall consider in good faith such BioCryst’s comments
with respect thereto.

(b) Filings and Correspondence. Shionogi shall promptly provide BioCryst with (i)
copies of all Regulatory Filings relating to the Territory submitted by Shionogi (in the original
language) and (ii) copies of material correspondence with Regulatory Authorities in the Territory
(including minutes of meetings, telephone conferences and/or discussions with such Regulatory
Authority) (in the original language). Shionogi agrees to assist BioCryst the English translation
of such documents at BioCryst’s cost.

(c) Regulatory Meetings. Shionogi shall promptly provide BioCryst with reasonable
advanced notice (to the extent practicable) of meetings, scheduled or unscheduled, with any
Regulatory Authority that pertain to a Licensed Product, and, to the extent not prohibited by
applicable Law, shall afford BioCryst’s representatives an opportunity to attend and participate in
all such meetings with relevant Regulatory Authorities as observers, to the

 

-9-

 

extent reasonably practicable under the circumstances. Likewise, BioCryst shall promptly
provide Shionogi with reasonable advanced notice (to the extent practicable) of meetings, scheduled
or unscheduled, with any Regulatory Authority that pertain to a Licensed Product developed by
BioCryst (for clarity, BioCryst itself, and not licensees of BioCryst) outside the Territory, and,
to the extent not prohibited by applicable Law, shall afford Shionogi’s representatives an
opportunity to attend and participate in all such meetings with relevant Regulatory Authorities as
observers, to the extent reasonably practicable under the circumstances.

(d) JSC Oversight. In addition to Section 3.2(a), (b) and (c) above with respect to
Regulatory Filings and meetings with Regulatory Authorities, Shionogi’s Development and
Commercialization activities, including the content and subject matter of, and strategy for, any
MAA, all correspondence submitted to Regulatory Authorities related to clinical trial design, all
proposed labeling and labeling discussions and decisions with Regulatory Authorities, and all
post-Marketing Approval labeling discussions and decisions with Regulatory Authorities (including
the final approved labeling), and post-Marketing Approval labeling changes or expansions, in each
case relating in any way to Licensed Product, shall be subject to reasonable oversight by the JSC.

3.3 Cooperation. Each Party agrees to make its personnel reasonably available, upon
reasonable notice by the other Party, at their respective places of employment to consult with the
other Party on issues arising related to the activities conducted in accordance with this Article 3
or otherwise relating to regulatory matters involving the Licensed Product, including any request
from any Regulatory Authority, including regulatory, scientific, technical and clinical testing
issues, or otherwise. Each Party (the “Enabling Party”) agrees to cooperate with the other (the
"Filing Party”), at its request, to comply with specific requests of a Regulatory Authority (such
as requests to inspect clinical trial sites), with respect to Data supplied or to be supplied by
the Enabling Party to the Filing Party for filing with such Regulatory Authority, or with respect
to Licensed Product supplied by the Enabling Party. The Enabling Party shall ensure that its
contractors likewise comply with this Section 3.3.

3.4 Use of Contractors. Subject to the terms of this Agreement, Shionogi shall have
the right to use the services of Third Party contractors, including contract research
organizations, contract sales forces and the like, to assist Shionogi in fulfilling its obligations
and exercising its rights under this Agreement, provided that each such Third Party is bound by a
written agreement, that is consistent with terms of this Agreement, including confidentiality and
intellectual property ownership provisions consistent with those set forth therein. Shionogi shall
provide BioCryst with quarter annual updates of the identity of all contractors who assist Shionogi
in exercising its rights or fulfilling its obligations hereunder. For the purposes of clarity,
Shionogi shall remain responsible for the performance by all such contractors.

3.5 Development Supply.

(a) From the Effective Date through ***, BioCryst will supply to Shionogi, at Shionogi‘s
expense, and Shionogi agrees to purchase exclusively from BioCryst, (i) the Licensed Product
(including its placebos if needed) for use in clinical studies to be conducted in the Territory by
or on behalf of (subject to the terms of Section 3.4, above) Shionogi, and (ii) the Compound
necessary for the Development of the Licensed Product.

 

-10-

 

(b) On ***, BioCryst will supply Shionogi with Compound (at Shionogi’s expense) and Shionogi
will have established the necessary resources to formulate Licensed Product from Compound for
clinical use. The Parties agree to evaluate in good faith the above arrangement on an ongoing
basis to ensure the timely progression and development of the Licensed Product in the Territory.

(c) During the term of this Agreement, BioCryst shall supply to Shionogi, *** of Compound (in
such individual amounts and at such times as reasonably agreed upon by the Parties) for Shionogi to
use Diligent Efforts to develop an optimized intramuscular formulation of the Compound for use by
Shionogi in the Territory and for use by BioCryst outside the Territory pursuant to Section 10.2.
In addition, if the Parties agree in writing that Shionogi may explore the possibility to Develop
New Formulations under mutually agreed conditions, BioCryst shall also supply to Shionogi, *** (but
upon such additional terms and conditions as the Parties may agree), the Compound for Development
of such New Formulation. Both Parties understand and agree that there are no assurances that
Shionogi’s efforts will generate an optimized intramuscular formulation of the Compound or lead to
the successful Development of New Formulations.

(d) All Licensed Product and Compound delivered by BioCryst to Shionogi shall be manufactured
in accordance and in compliance with the specifications to be determined by BioCryst; provided,
however that BioCryst shall give due consideration to revised specifications (if any) requested by
Shionogi. BioCryst shall carry out its responsibilities hereunder in conformance with cGMPs and
all other applicable Laws (all of the foregoing, in the United States). All supply of Licensed
Product and Compound shall be subject to the terms and conditions set forth in this Section 3.5 and
shall be subject to the terms and on prices as attached in Schedule 3.5 hereto.

(e) BioCryst shall transfer to Shionogi the formulation and manufacturing processes that (i)
are maintained or subsequently developed or optimized by BioCryst and (ii) are designed to ensure
the quality of Licensed Product. All transfer of such Know-How shall take place in Birmingham,
Alabama unless otherwise agreed upon by the Parties. If the transfer is to occur wholly or
partially outside of Birmingham, Alabama, then Shionogi shall promptly ***.

3.6 Commercial Supply. BioCryst will supply to Shionogi, at Shionogi’s expense, and
Shionogi agrees to purchase exclusively from BioCryst, Compound in bulk powder form for purposes of
Commercialization in the Territory. Such supply shall be subject to the terms and on prices as
attached in Schedule 3.5 hereto. Shionogi shall be responsible for manufacturing Licensed Product
from Compound provided by BioCryst to Shionogi.

3.7 Covenant and Manufacturing Option. For the avoidance of doubt, the Parties hereby
agree that they intend that BioCryst supply, and Shionogi exclusively purchase from BioCryst,
Compound for all uses contemplated in this Agreement. Shionogi hereby acknowledges and agrees that
it has no rights to, and shall not (and it and its Affiliates shall not otherwise) manufacture or
have manufactured or purchase from a Third Party Compound unless otherwise agreed in writing
between BioCryst and Shionogi. However, Shionogi shall have the option to manufacture or have
manufactured Compound for the Territory; ***. In the event that Shionogi exercises such option to
manufacture Compound, BioCryst shall transfer to

 

-11-

 

Shionogi all BioCryst Know-How or other technologies relating to manufacture of the Compound.
All transfer of such Know-How shall take place in Birmingham, Alabama unless otherwise agreed upon
by the Parties. If the transfer is to occur wholly or partially outside of Birmingham, Alabama,
then Shionogi shall ***. In such event, all products Commercialized in the Field which derive from
such Compound shall be deemed for all purposes hereunder to be a Licensed Product.

ARTICLE 4

GOVERNANCE

4.1 Joint Steering Committee. Promptly following the Effective Date, but no later
than forty-five (45) days after the Effective Date, the Parties shall establish a joint steering
committee (the "Joint Steering Committee” or "JSC") to oversee, review and coordinate the conduct
and progress of the Development of Licensed Product in the Territory. The JSC shall be responsible
for, among other things: annually reviewing and updating the Development Plan; monitoring the
competitive landscape for the Licensed Product in the Territory; and undertaking such other
matters as are specifically provided for the JSC under this Agreement. Shionogi shall keep the JSC
fully informed of progress and results of its activities under the Development Plan through its
members on the JSC and as otherwise provided herein.

4.2 Committee Membership. The JSC shall be comprised of an equal number of
representatives from each of BioCryst and Shionogi. The exact number of such representatives shall
initially be three (3) for each of BioCryst and Shionogi, or such other number as the Parties may
agree. The initial members of the JSC shall be as set forth on Exhibit A. Either Party may
replace its respective committee representatives at any time with prior written notice to the other
Party. Unless otherwise agreed, the JSC shall have at least one representative with relevant
decision-making authority from each Party such that the JSC is able to effectuate all of its
decisions within the scope of its responsibilities. In the event a JSC member from either Party is
unable to attend or participate in a JSC meeting, the Party who designated such representative may
designate a substitute representative for the meeting in its sole discretion.

4.3 Subcommittees. From time to time, the JSC may establish subcommittees to oversee
particular projects or activities, and such subcommittees will be constituted as the JSC approves
(each, a “Subcommittee”). If any Subcommittee is unable to reach a decision on any matter after
endeavoring in good faith for *** to do so, such matter shall be referred to the JSC for resolution
as provided in Section 4.6.

4.4 Committee Co-Chairs. Each Party shall appoint one of its members to the JSC to
co-chair the JSC’s meetings (each, a “Co-Chair”). The Co-Chairs shall (i) ensure the orderly
conduct of the JSC’s meetings, (ii) attend each JSC meeting (either in-person, videoconference or
telephonically), and (iii) prepare and issue written minutes of each meeting within thirty (30)
days thereafter accurately reflecting the discussions and decisions of such Committee. In the event
the Co-Chair from either Party is unable to attend or participate in a JSC meeting, the Party who
designated such Co-Chair may designate a substitute Co-Chair for the meeting in its sole direction.

 

-12-

 

4.5 Committee Meetings. The JSC shall meet quarterly, or as more or less often as
otherwise agreed by the Parties, and such meeting may be conducted by telephone, videoconference or
in person as determined by the Co-Chairs. As appropriate, other employee representatives of the
Parties may attend JSC meetings as nonvoting observers if mutually agreed by the Parties. Each
Party may also call for special meetings of the JSC to resolve particular matters requested by such
Party and within the areas of responsibility of the JSC. Each Co-Chair shall ensure that its JSC
members receive adequate notice of such meetings.

4.6 Decision Making. Decisions of the JSC shall be made by consensus of the members
present in person or by other means (e.g., teleconference) at any meeting, with each Party having
one vote. In order to make any decision, the JSC must have present (in person, videoconference or
telephonically) at least one representative of each Party. All decisions of the JSC shall be
consistent with the Guiding Principle. Notwithstanding anything herein to the contrary, the JSC
shall have no authority to amend, modify or waive compliance with this Agreement. In the event
that the JSC cannot reach agreement with respect to any matter that is subject to its
decision-making authority, then the matter shall be resolved pursuant to the provisions set forth
in Article 15 (“Dispute Resolution”).

4.7 Performance of Representatives. BioCryst and Shionogi shall cause each of their
representatives on the JSC and any other committee (including Subcommittees) or team established
under this Agreement to vote, and shall otherwise perform their respective activities under this
Agreement, in a good faith manner consistent with the Guiding Principle.

4.8 Day-to-Day Decision-Making Authority. Shionogi shall have decision making
authority with respect to the day-to-day operations of the Development and Commercialization of
Licensed Product in the Territory, provided that such decisions are not inconsistent with the Plans
or the Guiding Principle, other decisions of the JSC and any other committee (including
Subcommittees) or team established under this Agreement within the scope of their authority
specified therein, or the express terms and conditions thereof.

ARTICLE 5

DEVELOPMENT

5.1 General. Shionogi shall use Diligent Efforts to Develop in the Territory
Licensed Product for use in the Field, all in accordance with the Development Plan. Shionogi shall
be responsible for conducting, and shall use Diligent Efforts to conduct, the activities set forth
in the Development Plan to progress and complete such activities within the timeframes set forth in
the Development Plan. Shionogi agrees not to perform, directly or indirectly (or through any Third
Party on behalf of Shionogi), any Development activities outside the Territory with respect to any
Licensed Product, and not to perform any Development activities in or for use in the Territory with
respect to any Licensed Product except in accordance with the Development Plan or, in each case, as
otherwise provided herein. Shionogi shall pay due consideration to the protocols and desired
endpoints in the trials sponsored by BioCryst in preparing the protocols for the clinical trials to
be conducted by or on behalf of Shionogi in the Territory.

5.2 Product Development outside the Territory. 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).

 

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5.3 Development Reports. Within thirty (30) days after the end of each calendar
quarter, Shionogi shall prepare and provide to BioCryst a written report that (i) summarizes the
progress of the Development activities performed by Shionogi hereunder during the preceding
calendar quarter, (ii) identifies any issues or circumstances of which it is aware that may prevent
or adversely affect in a material manner the activities under the Development Plan in the
then-current calendar quarter, and, to the extent reasonably practicable, (iii) identifies steps
that may be taken, or changes that may be made, to resolve such issues. Shionogi shall maintain
records in sufficient detail as will properly reflect all work done in the performance of
activities arising out of, in conducting, or otherwise in connection with its Licensed Product
Development activities. Likewise, BioCryst shall prepare and provide to Shionogi a quarterly
written report summarizing the Development performed by BioCryst outside the Territory in
reasonable detail. To the extent known by BioCryst and permitted by its licensees (and not
otherwise prohibited by Law), BioCryst shall provide the foregoing information to Shionogi relating
to BioCryst’s licensees outside of the Territory, provided that Shionogi shall keep such
information strictly confidential pursuant to Section 11.2. BioCryst shall also provide Shionogi
with its development plan and any amendment thereto in a timely manner.

5.4 Interactions Between Committees and Internal Teams. The Parties recognize that
while they will establish the various committees and teams for the purposes hereof, each Party
maintains internal structures (including its own committees, teams and review boards) that will be
involved in administering such Party’s activities under this Agreement. The Parties shall
establish procedures (including the appointment of alliance managers) to facilitate communications
between the various committees and teams hereunder and the relevant internal committee, team or
board within the Party in order to maximize the efficiency of the Parties’ activities pursuant to
this Agreement. In addition, each of the Joint Steering Committee and any subcommittee shall
coordinate with each other as appropriate.

5.5 Development Costs. Development Costs relating to the Licensed Product in the
Territory shall be borne 100% by Shionogi, subject to Section 2.5(c).

5.6 Clinical Milestone Events. Shionogi shall use Diligent Efforts to achieve the
events set forth in the table below (each a “Milestone Event”) by the date set forth in the table
below (each a “Milestone Date”) in furtherance of the Development of the Licensed Products. The
Parties agree that the JSC shall have forty-five (45) days from the Effective Date to review, and
comment on the Milestone Events contained herein and shall use such Milestone Events contained
herein as a framework to create other more detailed steps it feels necessary to Develop the
Licensed Products. Any changes or additions to the Milestone Events or Milestone Dates made by the
JSC shall be made in good faith and shall be consistent with the Guiding Principles and shall be
included in the Development Plan.

	 	 	 	 	 
	Milestone Event	 	Milestone Date	 
	 	 	 	 	 
	Submission of the first Phase II
Clinical Trial protocol to MHLW or
the applicable Regulatory Authority
in the Territory
	 	 	***	 
	 	 	 	 	 
	Submission of the first Phase III
Clinical Trial protocol to MHLW or
the applicable Regulatory Authority
in the Territory
	 	 	***	 
	 	 	 	 	 
	Submission of NDA to MHLW or the
applicable Regulatory Authority in
the Territory
	 	 	***	 

 

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ARTICLE 6

COMMERCIALIZATION

6.1 General. Shionogi undertakes that it will Commercialize the Licensed Products in
the Territory and carry out its obligations hereunder in compliance with all applicable Laws.

6.2 Commercialization Plan. Shionogi shall, beginning *** prior to the anticipated
date of Marketing Approval for a Licensed Product in the Territory and continuing until the
expiration of the term of this Agreement, prepare and submit to BioCryst for its review and comment
(which comments Shionogi shall consider reasonably and in good faith), a Territory-wide plan for
the Commercialization of such Licensed Product in the Field following receipt of the requisite
Marketing Approval (a “Commercialization Plan”) covering in detail (to the extent available) the
*** period prior to the first anticipated date on which such Licensed Product would be first
shipped in commercial quantities for commercial sale to Third Parties in the Territory, and
providing general plans (with an estimated Budget) for the *** period following such anticipated
shipping date. On or before December 15 of each calendar year, Shionogi shall update each
Commercialization Plan to include detailed plans for the following calendar year (with an estimated
Budget), and shall submit such updated Commercialization Plan to BioCryst for its review and
comment (which comments Shionogi shall reasonably consider in good faith). Each Commercialization
Plan shall include a detailed description of each Commercialization activity to be conducted in the
Territory thereunder, including the following, as applicable:

(a) ***;

(b) ***;

(c) ***;

(d) ***;

(e) ***;

 

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(f) ***;

(g) ***;

(h) ***;

(i) ***

(j) ***.

6.3 Amendments. Shionogi shall review the Commercialization Plans on a regular basis
during each calendar year and shall promptly submit any significant modifications of such plans to
BioCryst for review and comment (which comments Shionogi shall reasonably consider in good faith).

6.4 Promotional Material. No later than *** prior to the expected date of National
Health Insurance (NHI) price listing for the first Licensed Product in the Territory, Shionogi
shall provide BioCryst with a representative example of its proposed major Promotional Material,
and BioCryst shall have the right to make comments or observations thereon within *** of its
receipt thereof. Thereafter, Shionogi shall provide BioCryst with a representative example of its
Promotional Material as soon as practicable after BioCryst’s written request, such a request shall
not be made more than once each calendar year, and BioCryst shall have the right to make comments
or observations thereon within *** of its receipt thereof. Notwithstanding BioCryst’s right to
make comments or observations, and other than with respect to the BioCryst Logos (with respect to
which BioCryst shall have sole decision-making power, even with respect to Shionogi’s Promotional
Literature) all other decisions with respect to Shionogi’s Promotional Material shall be made by
Shionogi in its sole discretion after in good faith taking into consideration BioCryst’s comments
and observations.

6.5 Costs of Commercialization. Shionogi shall be responsible for all costs
associated with the Commercialization of Licensed Products within the Territory.

6.6 Trademark. Shionogi shall have the right to select the trademark, from among the
stocks of trademarks of Shionogi or BioCryst to be used in connection with the Commercialization
of the Licensed Product in the Territory after paying due consideration of the opinions of the JSC.
If Shionogi selects a registered trademark owned by BioCryst in the Territory, BioCryst shall
grant to Shionogi a royalty-free license to use such trademark for the Licensed Product in the
Field and in the Territory for the term of this Agreement upon such additional terms as BioCryst
may request. If Shionogi selects its own registered trademark for use on Licensed Products in the
Territory (the “Licensed Product Mark”), the ownership of such Licensed Product Mark shall remain
in Shionogi and such Licensed Product Mark shall not be included in the BioCryst Marks.

6.7 Outside of Territory. Shionogi shall ensure that no Licensed Products are
Commercialized outside of the Territory. Shionogi shall ensure that no Licensed Products are
manufactured outside of the Territory, except as specifically provided herein.

 

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ARTICLE 7

ADVERSE EVENT AND PRODUCT COMPLAINT REPORTING

7.1 By Shionogi. Shionogi will promptly (a) provide BioCryst with all Licensed
Product complaints, adverse event information and safety data from clinical studies and
Commercialization in its control; and (b) report all such adverse events in the Territory in
accordance with Laws, and provide such information to BioCryst in such a manner and time so as to
enable BioCryst to comply with all applicable Laws outside the Territory. Shionogi shall maintain
a Territory-wide adverse event database for the Licensed Products and shall generate adverse event
reports for BioCryst’s use. BioCryst shall have free and unfettered access to all data in such
database. Shionogi shall be responsible for submitting adverse events reports to the applicable
Regulatory Authorities in the Territory. Shionogi shall bear 100% of the costs of adverse events
reporting and of maintaining the Territory-wide adverse events database.

7.2 By BioCryst. BioCryst will promptly (a) provide Shionogi with all Licensed
Product complaints, adverse event information and safety data from clinical studies and
Commercialization in its control; and (b) report all such adverse events outside the Territory in
accordance with Laws, and provide such information to Shionogi in such a manner and time so as to
enable Shionogi to comply with all applicable Laws in the Territory. BioCryst shall, at its own
cost, maintain a global adverse event database for the Licensed Products and shall generate adverse
event reports outside the Territory for Shionogi’s use. Shionogi shall have free and unfettered
access to all data in such database. BioCryst shall be responsible for submitting adverse events
reports to the applicable Regulatory Authorities outside the Territory, with respect to which
BioCryst shall bear 100% of the costs.

7.3 Adverse Events and Reporting. As soon as reasonably practicable, but in no event
later than three (3) months after the Effective Date, the Parties shall jointly establish, and
mutually agree upon adverse event and complaint reporting procedures which each Party must adhere
to and shall execute a separate agreement relating thereto. Such procedures shall at all times
include any measures necessary for each Party to fully comply with applicable Laws and such
procedures may be amended with the Parties’ mutual consent from time to time. Such operating
procedures and any material revisions to them shall be provided to the JSC for review and comment
before execution of the aforesaid agreement. In addition, each Party shall promptly notify the
other if such Party becomes aware of any information or circumstance that is likely to have a
material adverse effect on the Development or Commercialization of the Licensed Products.

ARTICLE 8

INSURANCE

8.1 Shionogi shall obtain and maintain, during the term of this Agreement, comprehensive
general liability insurance, including products liability insurance and coverage for clinical
trials, with reputable and financially secure insurance carriers in a form and at levels,
respectively, that are reasonable and customary in the pharmaceutical industry for companies of
comparable size and activities, but in any event shall be a minimum of *** per occurrence with an
annual aggregate limit of not less than ***. The premium of any insurance will be borne by
Shionogi. Such liability insurance shall be maintained on an occurrence basis to provide

 

-17-

 

such protection for *** after expiration or termination of this Agreement. Shionogi shall
furnish to BioCryst on request certificates issued by the insurance company setting forth the
amount of the liability insurance (or evidence of self insurance). BioCryst shall receive thirty
(30) days written notice prior to termination or material reduction to the level of Shionogi’s
insurance policy as required by this Article 8.

ARTICLE 9

PAYMENTS

9.1 Signing Fee. Within *** of the Effective Date, in partial consideration for the
licenses and rights granted to Shionogi under this Agreement, Shionogi shall pay or cause to be
paid, a non-refundable, non-creditable payment of Fourteen Million U.S. Dollars ($14,000,000) to
BioCryst as a signing fee (the “Signing Fee”).

9.2 Milestone Payments. As additional partial consideration for the licenses and
rights granted by BioCryst to Shionogi herein, Shionogi shall pay to BioCryst the following
one-time, non-refundable, non-creditable payments:

(a) ***. Notwithstanding the foregoing, in the event of bona fide extraordinary circumstances
relating to the profile of the Licensed Product which first arose during the Phase *** Trial ***,
the Parties will discuss in good faith extending the period for payment under Section 9.2(a)(i),
above, which in no event shall exceed the *** of receipt of the final case report form from the
Phase *** Trial for a Licensed Product in the Territory. If such bona fide safety concern is
related to a formulation and Shionogi notifies BioCryst of its good faith decision to re-conduct a
Phase *** Trial with a newly developed formulation, then the payment set forth in this Subsection
9.2 (a) shall be made no later than the earlier of ***. If such newly developed formulation again
demonstrates in Phase *** Trial a bona fide safety concern after re-conducting Phase *** Trial and
Shionogi has again made the good faith decision to repeat Phase *** Trial(s) with another newly
developed formulation, ***.

(b) *** in the Territory for a Licensed Product.

(c) *** in the Territory.

9.3 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, which
shall be paid within *** after the end of each calendar quarter:

(a) for sales of Licensed Products to any Governmental Entity ( “Non-Commercial Sales"), the
greater of ***. For the purposes of this Agreement, “Adjusted Net Sales” shall mean ***.

(b) for sales of Licensed Products to non-Governmental Entity parties (“Commercial Sales”),
royalty payments on incremental Net Sales according to the following rates for the following ranges
of Net Sales:

(i) ***.

 

-18-

 

(ii) ***.

By way of example ***:

	 	 	 	 	 	 	 	 	 
	Amount of Net Sales	 	Royalty Rate	 	 	Royalty Payment	 
	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**%	 	 	*	**
	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**%	 	 	*	**
	 	 	 	 	 	 	 	 	 
	***
	 	 	 	 	 	 	*	**

(c) Term. The term for the obligations to pay royalties under this Section 9.3 shall
expire on the date that is the later of (i) ***. 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.

(d) 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 the Territory,
then the royalty obligations from Shionogi to BioCryst shall be reduced by ***. If there is a
Valid Claim, and if

(i)

***                    , then ***

(ii)

***

Where :

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

(e) Third Party Rights. 

 

-19-

 

(i) New Formulations. In the event Third Party Intellectual Property Rights are
necessary (or desired by Shionogi) in order to Develop or Commercialize New Formulations of
Licensed Products in the Territory and BioCryst desires to obtain a license to such Third Party
Intellectual Property Rights for outside the Territory, Shionogi shall procure a worldwide
license to such Intellectual Property Rights from such Third Party (each, a “Third Party New
Formulations License”). Shionogi agrees (a) to keep BioCryst apprised of and involved in the
negotiations of such license, (b) to take into consideration BioCryst’s requests regarding the
same, and (c) not to execute any agreement for a Third Party New Formulations License with such
Third Party without obtaining BioCryst’s prior consent on the terms and conditions of such
agreement which relate to the license outside the Territory. If BioCryst obtains rights under the
Third Party New Formulations License outside the Territory, BioCryst shall bear royalties and
other payments owed to the licensing Third Party of such Third Party Intellectual Property Rights
outside the Territory. The Parties agree that no royalty offset (described in Section 9.3(e)(ii),
below) shall be available to Shionogi for payments made under Third Party New Formulations
Licenses.

(ii) Royalty Offset. In the event that, Shionogi, in order to exploit the licenses
and rights granted to it under Section 2.1 hereof, actually makes royalty or other payments to
one or more Third Parties (“Third Party Payments”) as consideration for a license to Intellectual
Property Rights of such Third Parties, in the absence of which the importation or use of Compound
or manufacture, use or sale of Licensed Product could not legally be made in the Territory due to
the infringement of valid claims in such Intellectual Property Rights of such Third Parties, then
Shionogi shall have the right to reduce the royalties otherwise due to BioCryst pursuant to this
Section 9.3 for such Licensed Product by *** of such Third Party Payments. Notwithstanding the
foregoing, the offset set forth in this Section 9.3(e) (ii) shall in no event reduce the royalty
for Licensed Product in the Territory by *** of the royalty rate otherwise due to BioCryst
pursuant to this Section 9.3.

(f) Royalty Reports. All royalty payments shall be accompanied by a written report
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) and any other information
customary with industry standards of the Territory.

9.4 One-time Net Sales Milestone Payments for Sales of Licensed Products. In partial
consideration for the licenses and rights granted to Shionogi under this Agreement, Shionogi shall
pay or cause to be paid, to BioCryst within *** of the first achievement of the following
milestones, the following one-time, non-refundable, non-creditable payments in the amounts set
forth next to such milestone:

	 	 	 
	Cumulative Calendar Year Net Sales	 	 
	including both Non-Commercial Sales	 	 
	and Commercial Sales	 	Payment (in U.S. Dollars)
	 	 	 
	• ***

	 	• ***
	 	 	 
	• ***

	 	• ***

 

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	Cumulative Calendar Year Net Sales	 	 
	including both Non-Commercial Sales	 	 
	and Commercial Sales	 	Payment (in U.S. Dollars)
	 	 	 
	• ***

	 	• ***
	 	 	 
	• ***

	 	• ***
	 	 	 
	Total Commercial Sales Milestone Payments:

	 	$95 million

9.5 Payments for Clinical and Commercial Supply. In consideration for the supply of
Licensed Product and Compound for Development and commercial use, Shionogi shall pay to BioCryst an
amount equal to ***.

9.6 Payments; Foreign Exchange. All amounts referenced herein are in United States
Dollars. Unless otherwise specified, all payments under this Agreement shall be made within thirty
(30) days of the date of invoice, in U.S. Dollars, by wire transfer to a bank and to an account
designated by BioCryst. Any payment amount, or any component used to calculate a payment amount,
computed in a currency other than the U.S. Dollar shall be converted into U.S. Dollars at the
exchange rate for transfers from such currency to U.S. Dollars as quoted by *** on the business day
immediately prior to the payment day. Any payments or portions thereof due hereunder which are not
paid when due shall bear interest equal to the lesser ***. This Section 9.6 shall in no way limit
any other remedies available to either Party. Other than as set forth herein or except in the case
of overpayment, all payments hereunder shall be non-refundable and non-creditable.

9.7 Taxes. The Parties agree that all amounts due by Shionogi to BioCryst under this
Agreement shall be treated as “royalties” for purposes of the U.S. Japan Income Tax Treaty.
Accordingly, all payments hereunder shall be made free and clear, and without deduction or
withholding, of any present or future taxes, duties, levies and other similar charges, including
related interest, additions to tax and penalties (“Taxes”). ***.

9.8 Audit Rights. Each Party shall have the right, at its own expense, to inspect the
other Party’s relevant financial books and records through an independent certified public
accountant designated by the auditing Party and reasonably acceptable to the Party being audited
upon at least fifteen (15) days advance written notice for the purpose of confirming the audited
Party’s compliance with the terms herein. Each Party and its Affiliates shall keep full, true and
accurate books of account containing all particulars that may be necessary for the purpose of
calculating all royalties and other payments payable under this Agreement and shall retain such
books of account for a minimum of *** after the applicable reporting period. Audit results and
findings shall be shared by the auditing Party with the audited Party. If the audit reveals an
underpayment, the audited Party shall make up such underpayment within thirty (30) days, plus
interest at the rate of ***. If the audit reveals an overpayment, the auditing Party shall return
such overpayment within thirty (30) days. If the audit reveals an underpayment or overpayment in
the amount of *** for any calendar quarter, then the audited Party shall reimburse the auditing
Party for the costs of the audit. Notwithstanding the foregoing, any
audit of BioCryst shall be limited to the books and records necessary in order to verify the
calculation of COGS.

 

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ARTICLE 10

INTELLECTUAL PROPERTY

10.1 Prosecution and Maintenance of BioCryst Patents. BioCryst shall prosecute and
maintain the BioCryst Patents as BioCryst reasonably determines. As between BioCryst and Shionogi,
BioCryst shall determine whether, where and when to maintain any of the BioCryst Patents and to
file any patent applications included in the BioCryst Patents and, if it determines to take any
action, it shall do so at its own cost and expense. However, with respect to the BioCryst Patent
Japanese *** (“Core Patent”), BioCryst undertakes to prosecute and maintain such Core Patent in the
Territory and shall provide Shionogi with copies of all material communications received from or
filed in patent office(s) in the Territory. In the event that BioCryst determines not to continue
to prosecute or maintain any of the BioCryst Patents, BioCryst shall notify Shionogi not less than
*** before any relevant deadlines. Thereafter, Shionogi shall have the right to pursue at its sole
cost and discretion the prosecution or maintenance of such patent application or patent. The
Parties shall reasonably cooperate with each other in gaining patent term extension(s) or the like
applicable to the BioCryst Patents in the Territory.

10.2 Inventions. The ownership of any improvements to the BioCryst Intellectual
Property Rights (including any Patents and any other BioCryst Intellectual Property Rights, whether
patentable or not) that include, are based on, or are derived from, Compound or Licensed Product
(or the Development or Commercialization thereof), BioCryst Patents or the BioCryst Know-How,
including but not limited to the Shionogi Know-How (“Agreement Improvements”, which for the
avoidance of doubt shall include Intellectual Property Rights underlying New Formulations and shall
include the Licensed Product Mark) shall be determined in accordance with the laws of inventorship
of the United States. Shionogi hereby grants to BioCryst an irrevocable, exclusive, worldwide,
perpetual, royalty-free, fully paid up, transferable and sublicensable right under Shionogi’s
interest in Agreement Improvements (including without limitation to Shionogi’s interest in joint
inventions made with BioCryst) to make, have made, use, sell, import, have imported, and otherwise
fully commercially exploit such inventions outside of the Territory in all fields and inside the
Territory outside of the Field (it being understood that the Licensed Product Mark shall not be
used by BioCryst inside the Territory). Notwithstanding the foregoing, in the case that Agreement
Improvements are relevant to Compound or Licensed Products (including New Formulations) and also
other products, technology or applications, then the foregoing license grant shall be deemed to be
non-exclusive.

10.3 Infringement by Third Party.

(a) Each Party shall notify the other Party promptly of any conduct on the part of Third
Parties that it deems to be a potential infringement, misappropriation, act of unfair competition,
dilution or other violation of the BioCryst Intellectual Property Rights.

 

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(b) BioCryst will have the first right, in its sole discretion and expense, to take any and
all action it deems necessary to stop such violation, including the bringing of an action based on
the BioCryst Intellectual Property Rights or for unfair competition with respect thereto. BioCryst
will exclusively control the prosecution or settlement of any such action and will bring such
action in the name of BioCryst only or in the name of both BioCryst and Shionogi. Shionogi shall
have the right (but not obligation) to participate in such action through its own counsel at
Shionogi’s cost. If BioCryst does not take any action to stop such violation within sixty (60)
days from the date when either of BioCryst or Shionogi notifies the other Party of such violation,
Shionogi shall have the right (but not obligation) to take any and all action it deems necessary to
stop such violation. In either case, the Parties shall provide all reasonable assistance to each
other and reasonably cooperate to prosecute or settle such action. Each of BioCryst and Shionogi
shall recover their respective actual out-of-pocket expenses or equitable proportions thereof
associated with any such action or settlement thereof from any monetary proceeds, damages and other
relief obtained by BioCryst and/or Shionogi. Any excess amount shall be retained by the Party in
charge of the enforcement action; provided, however, that if such party is Shionogi, all such
proceeds shall be deemed to be “Net Sales” under the terms of this Agreement, for which a royalty
shall be paid to BioCryst.

(c) In the event that any action is brought against BioCryst or Shionogi or any Affiliate of
either Party alleging the violation of the Intellectual Property Rights of a Third Party by reason
of the Development, manufacture or Commercialization of Compound and/or Licensed Product in the
Field and in the Territory, Shionogi shall have the first right, but not the obligation, to defend
itself and BioCryst in such action at its sole expense. BioCryst shall have the right to
participate in such action through its own counsel at BioCryst’s cost. The Parties shall provide
all reasonable assistance to each other and reasonably cooperate to defend or settle such action.
Neither Party shall assert counterclaims based on the BioCryst Intellectual Property Rights, or
compromise, settle or otherwise dispose of any such action without the other Party’s advice and
prior consent, provided that the Party not defending the action shall not unreasonably withhold its
consent to any settlement which does not have a material adverse effect on its business.

ARTICLE 11

PUBLICITY; CONFIDENTIALITY

11.1 Publicity.

(a) Oversight by Communications Subcommittee. The JSC shall constitute a
Communications Subcommittee. Prior to communicating or disclosing any publications, abstracts,
scientific presentations, websites, press releases or other disclosures relating to the
relationship of the Parties, each Party shall submit to the Communications Subcommittee a copy of
such communication or disclosure for review in accordance with this Agreement and guidelines
established by the Communications Subcommittee. Such guidelines shall include among other things a
process for ensuring submission of all such communications and disclosures by the Parties to the
Communications Subcommittee reasonably in advance of disclosure to allow sufficient time for
review, including the preparation of a communications calendar that anticipates disclosures
expected to be made during the following calendar quarter. If the Communications Subcommittee is
unable to agree upon the acceptability of a
public disclosure after endeavoring to do so in good faith, BioCryst’s Co-Chair shall have the
right to cast the deciding vote.

 

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(b) Prior Review. Each Party may disclose results and significant developments
regarding Licensed Product and other activities in connection with this Agreement from time to time
only with the approval of the other Party, which approval shall not be unreasonably withheld,
conditioned or delayed. Such disclosures may include achievement of significant events in the
research, Development (including regulatory process), manufacture or Commercialization of Licensed
Product under this Agreement or the receipt of material payments. When a Party (the “Requesting
Party”) elects to make any such public disclosure under this Section 11.1(b), it will give the
other Party (the “Cooperating Party”) through its Communications Subcommittee representatives, a
copy of any such statement and at least five (5) business days to review and comment on such
statement, it being understood that if the Cooperating Party does not notify the Requesting Party
in writing within such five (5) business day period of any objections, such disclosure shall be
deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to
agree on the text of any proposed disclosure in an expeditious manner. The principles to be
observed in such disclosures shall be accuracy, compliance with applicable Law and regulatory
guidance documents, and reasonable sensitivity to potential negative reactions of the FDA and/or
the MHLW or the applicable Regulatory Authority in the Territory (and their foreign counterparts).

(c) Publications. Except as required by applicable Law or court order, any
publication or presentation of Confidential Information (as defined below), including studies or
clinical trials carried out by a Party or the Parties under this Agreement shall be subject to the
oversight and guidelines of the Communications Subcommittee. The Communications Subcommittee shall
establish, promptly after the Effective Date, guidelines that (i) allow for each Party’s timely
review of all such publications or presentations, (ii) provide for protection of Confidential
Information and ensure coordination with other applicable joint-committees prior to any disclosure
of protectable subject matter, and (iii) ensure that all such publications and presentations are
consistent with good scientific practice and accurately reflect work done and the contributions of
the Parties. Unless otherwise mutually agreed upon by the Parties, (A) the Party desiring to
publish or present any (the “Publishing Party”) shall transmit to the other Party (the “Reviewing
Party”) for review and comment a copy of the proposed publication or presentation, at least ***
prior to the submission of the proposed publication or presentation to any Third Party; (B) the
Publishing Party shall postpone the publication or presentation for up to an additional *** upon
request by the Reviewing Party in order to allow the Reviewing Party to consider appropriate patent
applications or other protection to be filed on information contained in the publication or
presentation; (C) upon request of the Reviewing Party, the Publishing Party shall remove all
Confidential Information of the Reviewing Party from the information intended to be published or
presented; and (D) the Publishing Party shall consider all reasonable comments made by the
Reviewing Party to the proposed publication or presentation. For the avoidance of doubt, no
restriction set forth in this Section 11.1 shall apply to BioCryst’s actions outside the Territory.

 

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11.2 Confidential Information; Exceptions. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party shall
keep confidential and shall not publish or otherwise disclose or use for any purpose other
than as provided for in this Agreement any confidential and proprietary information or
materials of the other Party furnished to it by the other Party or learned by it from or through
its exercise of its rights pursuant to this Agreement (collectively, “Confidential Information”)
during the term hereof and for a period of five (5) years following the termination of this
Agreement; provided, however, that the obligation to keep a Party’s trade secrets confidential
shall survive for such time as such information remains a protected trade secret. For the
avoidance of doubt, Agreement Improvements shall be deemed to be the Confidential Information of
both Parties. Notwithstanding the foregoing, Confidential Information shall not include any
information to the extent that it can be established by written documentation of the receiving
Party that such information:

(a) was already known to the receiving Party, other than under an obligation of
confidentiality (except to the extent such obligation has expired or an exception is applicable
under the relevant agreement pursuant to which such obligation established), at the time of
disclosure;

(b) was generally available to the public or otherwise part of the public domain at the time
of its disclosure to the receiving Party;

(c) became generally available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in breach of this
Agreement; or

(d) was disclosed to the receiving Party, other than under an obligation of confidentiality
(except to the extent such obligation has expired or an exception is applicable under the relevant
agreement pursuant to which such obligation established), by a Third Party who had no obligation to
the disclosing Party not to disclose such information to others.

11.3 This Agreement. Each of the Parties agrees not to disclose to any Third Party
the terms and conditions of this Agreement without the prior approval of the other Party, except
(i) to advisors (including attorneys and accountants) on a need to know basis, in each case under
circumstances that reasonably ensure the confidentiality thereof, or (ii) under circumstances that
reasonably ensure the confidentiality of the information, to the extent necessary to comply with
the terms of agreements with Third Parties existing as of the Effective Date; provided, however,
that if a Party is required by Law to make any such disclosure of the terms or conditions of this
Agreement, it will give reasonable advance notice to the other Party of such disclosure requirement
and will use its reasonable efforts to secure confidential treatment of the terms and conditions
which the Parties agree should be maintained as confidential. In addition to the foregoing, with
respect to complying with the disclosure requirements of the U.S. Securities and Exchange
Commission, the Financial Services Agency of Japan (collectively the “Securities Authorities”) in
connection with any required filing with any of the Securities Authorities of this Agreement, the
filing Party shall provide to the other Party a copy of the proposed filing and the Parties shall
work cooperatively in good faith, taking into consideration the other Party’s suggestions,
regarding the text of the disclosure as well as information for which the filing Party will seek to
obtain confidential treatment. Notwithstanding the foregoing, the Parties shall agree upon and
release a mutual press release to announce the effectiveness of this Agreement together with a
corresponding Question & Answer outline for use in responding to inquiries about the Agreement;
thereafter, the Parties may each disclose to
Third Parties the information contained in such press release and Question & Answer outline
without the need for further approval by the other.

 

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11.4 Authorized Disclosure. Except as expressly provided otherwise in this Agreement,
each Party may use and disclose Confidential Information of the other Party as follows: (i) under
appropriate confidentiality provisions substantially equivalent to those in this Agreement, in
connection with the performance of its obligations or as reasonably necessary or useful in the
exercise of its rights under this Agreement in complying with the terms of agreements with Third
Parties existing as of the Effective Date; (ii) to the extent such disclosure is reasonably
necessary in filing or prosecuting patent, copyright and trademark applications in accordance with
this Agreement, prosecuting or defending litigation, complying with applicable governmental
regulations, obtaining regulatory approval or fulfilling post-approval regulatory obligations, or
otherwise required by Law, provided, however, that if a Party is required by Law to make any such
disclosure of the other Party’s Confidential Information it will, except where impracticable for
necessary disclosures (for example, in the event of medical emergency), give reasonable advance
notice to the other Party of such disclosure requirement and, except to the extent inappropriate in
the case of patent applications, will use its reasonable efforts to secure confidential treatment
of such Confidential Information required to be disclosed; (iii) in communication with advisors
(including lawyers and accountants) on a need to know basis, in each case under appropriate
confidentiality provisions substantially equivalent to those of this Agreement; or (iv) to the
extent mutually agreed to by the Parties. Notwithstanding the foregoing and for the avoidance of
doubt, Shionogi acknowledges and agrees that BioCryst may disclose to the U.S. Government or other
Regulatory Authority all Data received from Shionogi; provided, however, that in the event
BioCryst intends to disclose the Data or information (including databases) under a different
process than the process applied by Shionogi in its protocol, CSR and/or analytical report, then
BioCryst shall obtain Shionogi’s consent prior to such disclosure.

ARTICLE 12

SHIONOGI OPTION TO LICENSE OTHER PRODUCTS

12.1 Right of First Negotiation. BioCryst hereby grants ***.

12.2 ***.

ARTICLE 13

REPRESENTATIONS, WARRANTIES AND COVENANTS

13.1 By BioCryst. BioCryst hereby represents and warrants to, and covenants with,
Shionogi as follows:

(a) BioCryst is duly organized and validly existing under the Laws of its jurisdiction of
incorporation and has full corporate power and authority, and has taken all corporate action
necessary, to enter into and perform its obligations under this Agreement.

 

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(b) This Agreement is a legal, valid and binding obligation of BioCryst, enforceable against
BioCryst in accordance with its terms. Neither the execution and delivery of this Agreement by
BioCryst, nor the performance by BioCryst of its obligations hereunder, conflicts with any
agreement, instrument or understanding, oral or written, by which BioCryst is bound.

(c) To BioCryst’s knowledge, no authorization, consent, approval, license, exemption of or
filing or registration with any court or governmental department, commission, board, bureau, agency
or instrumentality, domestic or foreign, under any applicable Law currently in effect, is required
in connection with the execution and delivery of this Agreement by BioCryst, or the performance by
BioCryst of its obligations hereunder.

(d) BioCryst has sufficient right in and to BioCryst Patents and BioCryst Know-How to enable
it to carry out its obligations under this Agreement. To its best knowledge, BioCryst has not
committed and shall not commit any breach of the Pre-Existing Third Party License which will lead
to a forfeiture of the rights granted under this Agreement.

(e) BioCryst has not been debarred or the subject of debarment proceedings by any Regulatory
Authority. BioCryst shall not knowingly use in connection with the Development of Licensed Product
any employee, consultant or investigator that has been debarred or the subject or debarment
proceedings by any Regulatory Authority.

(f) BioCryst shall use diligent efforts in carrying out its obligations pursuant to this
Agreement, consistent with all applicable United States Laws and highest industry standards.

13.2 By Shionogi. Shionogi hereby represents and warrants to, and covenants with,
BioCryst as follows:

(a) Shionogi is duly organized and validly existing under the Laws of its jurisdiction of
incorporation and has full corporate power and authority, and has taken all corporate action
necessary, to enter into and perform its obligations under this Agreement.

(b) This Agreement is a legal, valid and binding obligation of Shionogi, enforceable against
Shionogi in accordance with its terms. Neither the execution and delivery of this Agreement by
Shionogi, nor the performance by Shionogi of its obligations hereunder, conflicts with any
agreement, instrument or understanding, oral or written, by which Shionogi is bound.

(c) To Shionogi’s knowledge, no authorization, consent, approval, license, exemption of or
filing or registration with any court or governmental department, commission, board, bureau, agency
or instrumentality, domestic or foreign, under any applicable Law currently in effect, is required
in connection with the execution and delivery of this Agreement by Shionogi, or the performance by
Shionogi of its obligations hereunder.

(d) Neither Shionogi nor any of its Affiliates have been debarred or the subject of debarment
proceedings by any Regulatory Authority. Neither Shionogi nor any of its Affiliates shall use in
connection with the Development of Licensed Product any employee,
consultant or investigator that has been debarred or the subject or debarment proceedings by
any Regulatory Authority.

 

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(e) Shionogi shall use Diligent Efforts in carrying out its obligations pursuant to this
Agreement, consistent with all applicable Laws and highest industry standards.

13.3 Disclaimer. ALL PATENTS, KNOW-HOW, DATA AND OTHER INTELLECTUAL PROPERTY RIGHTS,
AND ALL LICENSED PRODUCT AND COMPOUND PROVIDED HEREUNDER IS PROVIDED AS-IS. NEITHER PARTY MAKES
ANY REPRESENTATION OR WARRANTY WITH REGARD TO ANY PATENT, KNOW-HOW, DATA, LICENSED PRODUCT,
COMPOUND OR OTHERWISE IN CONNECTION WITH THIS AGREEMENT EXCEPT AS SPECIFICALLY SET FORTH IN THIS
AGREEMENT. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, EACH PARTY DISCLAIMS, AND WAIVES ALL
WARRANTIES OF AND TO, THE OTHER, EXPRESS OR IMPLIED, ARISING BY LAW OR OTHERWISE, WITH RESPECT TO
ANY LICENSED PRODUCT, BIOCRYST INTELLECTUAL PROPERTY RIGHTS OR OTHERWISE IN CONNECTION WITH THIS
AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OR DEALING OR USAGE
OF TRADE, AND ANY IMPLIED WARRANTY OF NONINFRINGEMENT.

OTHER THAN IN CONNECTION WITH A PARTY’S INDEMNITY OBLIGATIONS, A BREACH OF THE LICENSE GRANTS
TO SHIONOGI OR IN CONNECTION WITH AN INDEMNIFYING PARTY’S INDEMNITY OBLIGATIONS UNDER THIS
AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT,
INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, SPECIAL OR PUNITIVE DAMAGES WHATSOEVER RESULTING OR ARISING
FROM ANY CAUSE OR CLAIM WHATSOEVER, WHETHER BY TORT, OR CONTRACT OR OTHERWISE, INCLUDING BUT NOT
LIMITED TO LOSS OF PROFITS AND LOSS OF SAVINGS, BUSINESS DATA, OR GOODWILL. SHIONOGI’S SOLE AND
EXCLUSIVE REMEDY FOR DAMAGES RELATING TO LICENSED PRODUCT OR COMPOUND SUPPLIED BY BIOCRYST SHALL BE
REPLACEMENT BY BIOCRYST OF ANY NON-CONFORMING MATERIAL.

13.4 Compliance with Laws. Shionogi understands and acknowledges that BioCryst is
subject to regulation by agencies of the U.S. Government, including, but not limited to, the U.S.
Department of Commerce and the U.S. Treasury Department’s Office of Foreign Assets Control, both of
which regulate the import, export and diversion of certain products and technology from and to
certain countries. Any and all obligations of BioCryst to provide the Compound or Licensed
Product, as well as any other technical information or assistance, and all rights on the part of
Shionogi to perform its obligations hereunder, shall be subject in all respects to such United
States laws and regulations as shall from time to time govern the license and delivery of
technology and products abroad by persons subject to the jurisdiction of the United States,
including but not limited to regulations promulgated under Executive Order No. 12924 of August 19,
1994 issued pursuant to the President’s authority under the International Emergency Economic Powers
Act, Title 50 U.S. C., Chapter 35, Section 1701 et seq. and those contained in Title 31, Part 500
of the U.S. Code of Federal Regulations. Shionogi agrees to cooperate with BioCryst including,
without limitation, providing required documentation, in

 

-28-

 

order to comply with any and all applicable United States Laws and regulations. Shionogi
warrants that it shall comply with all United States Laws and regulations governing exports in
effect from time to time that are applicable to BioCryst as if such laws and regulations were
applicable to Shionogi. In the event any rights or obligations hereunder are or become illegal or
the subject of sanctions or restrictions, then BioCryst shall have the right, in its sole
discretion, to terminate, without penalty and immediately upon written notice, the provisions of
this Agreement which in BioCryst’s sole discretion relate to such restrictions.

ARTICLE 14

TERM AND TERMINATION

14.1 Term. The term of this Agreement shall commence on the Effective Date and shall
continue unless terminated pursuant to this Article 14.

14.2 Termination By BioCryst. Without limiting any other rights or remedies either
Party may have under this Agreement or otherwise, BioCryst shall have the right to terminate this
Agreement upon notice to Shionogi at any time in the event that the Pre-Existing Third Party
License is terminated (or modified to an extent that BioCryst cannot perform its obligations
hereunder), or if any of the following shall occur:

(a) if Shionogi breaches, in any material respect, any of its representations, warranties or
obligations under this Agreement, and, if curable, such breach is not cured within thirty (30) days
after Shionogi’s receipt of written notice of such breach; or

(b) if Shionogi suffers an Insolvency Event.

14.3 Termination By Shionogi.

(a) Termination for Breach. Without limiting any other rights or remedies either
Party may have under this Agreement or otherwise, Shionogi shall have the right to terminate this
Agreement upon written notice to BioCryst, if BioCryst breaches, in any material respect, any of
its representations, warranties or obligations under this Agreement, and, if curable, such breach
is not cured within thirty (30) days after BioCryst’s receipt of written notice of such breach.

(b) Termination without Cause. Shionogi shall have the right to terminate this
Agreement at any time at its discretion by providing BioCryst with *** prior written notice.
Shionogi agrees to terminate this Agreement pursuant to this Section 14.3(b) in the event that, at
any time, Shionogi does not plan to exercise, or has not exercised, or will not exercise, Diligent
Efforts to Develop or Commercialize Licensed Products.

14.4 Effect of Termination.

(a) The termination or expiration of this Agreement shall not affect any payment of any debts
or obligations accruing prior to such date of termination or expiration. Sections *** shall
survive the termination or expiration of this Agreement.

 

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(b) Furthermore, upon termination of this Agreement all licenses and rights granted to
Shionogi shall terminate, and Shionogi shall terminate all activities related to the Development
and Commercialization of Licensed Products, cease all use of the BioCryst Intellectual Property
Rights, and shall return to BioCryst all documents (including copies) of any kind concerning the
Compound, BioCryst Intellectual Property Rights or the Licensed Products and other Confidential
Information received from BioCryst or otherwise created in the course of performing this Agreement.
Shionogi shall promptly destroy all Compound and Licensed Product which it holds in stock at the
time of such termination or expiration of this Agreement. Shionogi shall promptly and diligently
provide to BioCryst all assistance reasonably necessary in order to assist BioCryst in
transitioning and assigning to BioCryst all aspects of the Parties’ relationship hereunder,
including but not limited to all work in progress, regulatory submissions, Agreement Improvements
and Shionogi Know-How to BioCryst. For the avoidance of doubt, and in consideration for BioCryst’s
granting the New NI Compound option to Shionogi, Shionogi hereby assigns to BioCryst all
Intellectual Property Rights in the Agreement Improvements (to the extent that such Agreement
Improvements are solely related to the Compound and/or Licensed Product; and to the extent such
Agreement Improvements are not solely related to the Compound and/or Licensed Product, Shionogi
will and hereby does grant to BioCryst an irrevocable, non-exclusive, worldwide, perpetual,
royalty-free, fully paid up, transferable and sublicensable right under Shionogi’s interest in such
Agreement Improvements), and agrees to take all further actions reasonably requested by BioCryst to
perfect such assignment and vest the rights assigned to BioCryst in BioCryst or its designee(s).
Shionogi shall pay to BioCryst any and all amounts already due under this Agreement and transfer
and assign to BioCryst any Regulatory Filings relating to the Licensed Product that are in
Shionogi’s possession (including and but not limited to any IND, MAA, Marketing Approval or any
approval for any product labeling or Promotional Materials owned by or held in the name of Shionogi
or its Affiliates), including the ownership thereof.

(c) In the event of termination of this Agreement by a Party for the other Party’s uncured
material breach, such termination shall not affect the terminating Party’s right to claim damages
against the breaching Party for such breach. In the event the non-breaching Party waives its right
under Section 14.3 to terminate, such non-breaching Party shall not be prevented from seeking
damages for a material breach by the breaching Party during the Term of this Agreement.

ARTICLE 15

DISPUTE RESOLUTION

15.1 General. Any dispute or disagreement between the Parties arising out of, under
or in connection with this Agreement shall be settled in accordance with this Article 15.

15.2 Informal Mediation. In the event any dispute or disagreement between the Parties
arises out of, under or in connection with this Agreement, either Party shall submit the dispute to
the following executives for resolution: for BioCryst, Senior Executive Officer responsible for
corporate development (or such successor as may be named by BioCryst); for Shionogi: General
Manager of License Department responsible for alliance management (or such successor as may be
named by Shionogi). Such executives shall work together in good faith for a period of *** to
resolve the dispute.

 

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15.3 Escalation. In the event that a dispute is not resolved pursuant to the
provisions of Section 15.2, above, the dispute or disagreement shall be submitted to the Senior
Officers (defined below) for resolution. In such event, either Party, by written notice to the
other Party, may formally request that the dispute be resolved by the Senior Officers, specifying
the nature of the dispute with sufficient specificity to permit adequate consideration by the
Senior Officers. The Parties shall cause their respective Senior Officers to use commercially
reasonable efforts to resolve the referred dispute in good faith within *** of receiving such
written notification, including, without limitation, by means of a face-to-face meeting if
requested by either Party. “Senior Officers” means, for Shionogi, the Senior Executive Officer or
similar ranking officer, and for BioCryst, the CEO or similar ranking officer.

15.4 Arbitration. Any disputes, controversies between the Parties arising under or in
connection with this Agreement not resolved through the procedures set out in the preceding clauses
of this ARTICLE 15 shall be finally settled by arbitration without the right to appeal, in New York
City, if requested by Shionogi, or in Osaka, if requested by BioCryst, before a panel of three (3)
arbitrators under the Rules of the International Chamber of Commerce (“ICC Rules”), which Rules are
deemed to be incorporated by reference to this clause. Each Party shall nominate an arbitrator,
and the Party-nominated arbitrators shall agree upon the third arbitrator who will be the chair of
the arbitrate tribunal. If the two Party-nominated arbitrators are unable to agree upon the chair,
the chair shall be selected as provided in the ICC Rules. The arbitration award shall be binding
upon the Parties and enforceable by any court of competent jurisdiction. The arbitration award
shall include an award as to costs including attorney fees. These provisions shall not prevent a
Party from making application to any court of competent jurisdiction seeking equitable relief in
case of urgency.

15.5 No Arbitration of Intellectual Property Issues. Notwithstanding anything to the
contrary contained herein, unless otherwise agreed by the Parties, disputes relating to
Intellectual Property Rights shall not be subject to arbitration, and shall be submitted to a court
of competent jurisdiction.

ARTICLE 16

INDEMNIFICATION

16.1 Indemnification by Shionogi. Shionogi shall indemnify, defend, and hold
harmless BioCryst, the Affiliates of BioCryst, and their respective officers, directors, managers,
members, partners, owners, employees, licensees, successors, and assigns (collectively, the
"BioCryst Indemnitees”) from and against all actions, causes of action, suits, debts, obligations,
losses, damages, amounts paid in settlement, liabilities, costs, and expenses whatsoever, including
reasonable attorneys’ fees (collectively, “Losses”), whether arising out of a claim involving a
Third Party or between the Parties, resulting to, imposed upon, asserted against, or incurred by
any of BioCryst Indemnitees in connection with, or arising out of or relating to this Agreement,
including without limitation, the Licensed Products and the Development or Commercialization
thereof (including but not limited to product liability claims and recalls in the Territory),
and/or any breach by Shionogi of a representation, warranty or covenant under this Agreement.

 

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16.2 Indemnification by BioCryst. BioCryst shall indemnify, defend, and hold harmless
Shionogi, the Affiliates of Shionogi, and their respective officers, directors, managers, members,
partners, owners, employees, licensees, successors, and assigns (collectively, the “Shionogi
Indemnitees”) from and against all Losses, whether arising out of a claim involving a Third Party
or between the Parties, resulting to, imposed upon, asserted against, or incurred by any of
Shionogi Indemnitees in connection with, or arising out of or relating to (a) any material breach
of this Agreement by BioCryst or (b)the gross negligence or willful misconduct on the part of
BioCryst.

16.3 Indemnification Procedures. If any claim, demand, action or proceeding is made
or commenced by any Third Party (a “Third-Party Claim”) against any BioCryst Indemnitee or Shionogi
Indemnitee that is entitled to be indemnified with respect thereto under this ARTICLE 16 (the
"Indemnified Party”), the Indemnified Party shall give the other Party (the “Indemnifying Party”)
prompt written notice thereof; the failure to give such written notice shall not affect the
liability of the Indemnifying Party under this Agreement except to the extent such failure
materially and adversely affects the ability of the Indemnifying Party to defend the Third-Party
Claim. The Indemnifying Party shall have the right to assume the defense and resolution of the
Third-Party Claim, provided that (i) the Indemnified Party shall have the right to participate in
the defense of the Third-Party Claim at its own expense through counsel of its choice (control of
the defense will remain with the Indemnifying Party), (ii) the Indemnifying Party shall not
consent to the entry of any judgment or enter into any settlement that would require any act or
forbearance on the part of the Indemnified Party or which does not unconditionally release the
Indemnified Party from all liability in respect of the Third-Party Claim without the prior written
consent of the Indemnified Party, which consent shall not be unreasonably withheld, conditioned or
delayed, and (iii) the Indemnified Party may undertake the defense of the Third-Party Claim, at the
Indemnifying Party’s expense, if the Indemnifying Party fails promptly to assume and diligently to
prosecute the defense.

ARTICLE 17

MISCELLANEOUS

17.1 Assignment. This Agreement and any rights granted hereunder are personal to each
Party and shall not be sold, assigned, sublicensed, encumbered or otherwise transferred (each a
"Transfer”), directly or indirectly, by operation of law or otherwise, by either Party without the
prior written consent of the other Party, which consent may be granted or withheld in such other
Party’s sole discretion; provided, however, that BioCryst, without notice and at any time for any
reason, may Transfer this Agreement in whole or in part to (i) any of its Affiliates who agree to
be bound by the terms and conditions of this Agreement or (ii) to any successor of BioCryst by
merger, sale of all or substantially all of its business assets to which this Agreement relates or
otherwise. Any attempted Transfer of this Agreement or any of the rights granted hereunder in
violation of this Section 17.1 shall be void ab initio. The consent by any Party to any Transfer
shall not constitute a waiver of the necessity for such consent in any subsequent Transfer.
Notwithstanding anything to the contrary contained in this Section 17.1, either Party shall have
the right to assign its rights under this Agreement in connection with a Change of Control of such
Party to the successor in interest to such Party; provided, however, that the Party effecting a
Change of Control shall give written notice of such Change of Control
to the other Party within ten (10) days of such Change of Control, and such Transfer shall not
relieve such assigning Party of its obligations under this Agreement except to the extent any
permitted assignee assumes in writing the obligations of the assigning Party under this Agreement.

 

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17.2 Section 365(n). All licenses granted under this Agreement are deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual
property” as defined in Section 101 of such Code. In addition, if Shionogi desires to register
license granted hereunder with the Japanese Patent Office, BioCryst shall provide reasonable
cooperation to this end.

17.3 Governing Law; Venue. This Agreement 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 of New York. All actions arising under this Agreement 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.

17.4 Severability. If any one or more of the provisions of this Agreement shall be
held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the
remaining provisions hereof shall not in any way be affected or impaired thereby. In the event any
provisions shall be held invalid, illegal or unenforceable, the Parties shall use best efforts to
substitute a valid, legal and enforceable provision, which, insofar as practical, implements the
purposes hereof.

17.5 Notices. All notices, requests, demands and other communications hereunder shall
be given in writing and shall be: (a) personally delivered; (b) sent by telecopier, facsimile
transmission or other electronic means of transmitting written documents; or (c) sent to the
Parties at their respective addresses indicated herein by registered or certified U.S. mail, return
receipt requested and postage prepaid, or by private overnight mail courier service. The
respective addresses to be used for all such notices, demands or requests are as follows:

If to BioCryst, to:

BIOCRYST PHARMACEUTICALS, INC.

2190 Parkway Lake Drive

Birmingham, Alabama 35244

USA

Attention: CEO

Facsimile No.: +1-205-4640

 

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with a copy to:

Proskauer Rose LLP

1585 Broadway

New York, New York 10036-8299

USA

Attention: Daryn Grossman, Esq.

Telephone: +1-212-969-3000

Facsimile: +1-212-969-2900

or to such other person or address as BioCryst shall furnish to Shionogi in writing.

If to Shionogi, to:

SHIONOGI & CO., LTD.

12-4, Sagisu 5 chome

Fukushima-ku, Osaka 553-0002

Japan

Attention: General Manager, License Department

Telephone: +81-6-6455-2393

Facsimile: +81-6-6455-2053

or to such other person or address as Shionogi shall furnish to BioCryst in writing.

If personally delivered, such communication shall be deemed delivered upon actual receipt; if
electronically transmitted pursuant to this paragraph, such communication shall be deemed delivered
on the day transmitted unless it is received after 5:00 p.m., local time, or on a day which is not
a business day, in which case it shall be deemed delivered on the next business day after
transmission (and sender shall bear the burden of proof of delivery); if sent by overnight courier
pursuant to this paragraph, such communication shall be deemed delivered upon receipt; and if sent
by mail pursuant to this paragraph, such communication shall be deemed delivered as of the date of
delivery indicated on the receipt issued by the relevant postal service; or, if the addressee fails
or refuses to accept delivery, as of the date of such failure or refusal. Either Party may change
its address for the purposes of this Agreement by giving notice thereof in accordance with this
Section 17.4.

17.6 No Waiver. None of the provisions of this Agreement can be waived except in a
writing signed by the Party granting the waiver. No failure by a Party to exercise any right under
this Agreement shall operate as a waiver of such right, nor shall any single or partial exercise of
any right preclude any other or further exercise of that right or the exercise of any other rights.
The waiver by any Party of any breach of this Agreement shall not be deemed a waiver of any prior
or subsequent breach. All remedies of either Party shall be cumulative and the pursuit of one
remedy shall not be deemed a waiver of any other remedy.

17.7 Further Assurances. Each Party shall execute, acknowledge and deliver, without
additional consideration, such further assurances, instruments and documents, and shall take such
further actions, as the other Party shall reasonably request in order to fulfill the intent of this
Agreement and the transactions contemplated hereby.

 

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17.8 No Third-Party Beneficiaries. Nothing in this Agreement is intended or shall be
construed to give any other person or entity any legal or equitable right, remedy or claim under or
in respect of this Agreement or any provision contained herein, other than BioCryst Indemnitees,
Shionogi Indemnitees and any assignee permitted under Section 17.1 above.

17.9 Relationship of the Parties. The relationship of the Parties under this
Agreement shall be solely that of independent contractors and nothing herein shall be construed to
create or imply any relationship of employment, agency, joint venture, partnership or any
relationship other than that of independent contractors. BioCryst and Shionogi acknowledge and
agree that each of them is engaged in a separate and independent business and neither shall state,
represent or imply any interest in or control over the business of the other.

17.10 Government Funding. BioCryst’s obligations under this Agreement have been funded
in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness,
Office of Public Health Emergency Medical Countermeasures, under Contract No, HHSO100200700032C.

17.11 Cost. Unless otherwise specified, each Party shall bear the full Cost of its
compliance with the terms of this Agreement and its respective obligations hereunder. For purposes
of this Agreement, the term “Costs” when used herein means the fully allocated costs including but
not limited to the fully allocated cost of goods and services and manufacturing overhead directly
related to Licensed Product, and allocation of all administrative and general expenses directly
related to Licensed Product. Costs shall be determined by generally accepted accounting
principles, applied on a consistent basis.

17.12 Interpretation. The captions and headings to this Agreement are for convenience
only, and are to be of no force or effect in construing or interpreting any of the provisions of
this Agreement. Unless specified to the contrary, references to Articles, Sections, Schedules or
Exhibits mean the particular Articles, Sections, Schedules or Exhibits to this Agreement and
references to this Agreement include all Exhibits and Schedules attached hereto. Each accounting
term used herein that is not specifically defined herein shall have the meaning given to it under
GAAP, but only to the extent consistent with its usage and the other definitions in this Agreement.
Unless context otherwise clearly requires, whenever used in this Agreement: (i) the words
"include” or “including” shall be construed as incorporating, also, “but not limited to” or
"without limitation;” (ii) the word “day”, “month” or “year” means a calendar day, month or year
unless otherwise specified; (iii) the word “notice” means notice in writing (whether or not
specifically stated) and shall include notices, consents, approvals and other written
communications contemplated under this Agreement; (iv) the words “hereof,” “herein,” “hereby” and
derivative or similar words refer to this Agreement (including any Exhibits and Schedules); (v)
provisions that require that a Party, the Parties or any committee or team hereunder “agree,”
"consent” or “approve” or the like shall require that such agreement, consent or approval be
specific and in writing, whether by written agreement, letter, approved minutes or otherwise; (vi)
words of any gender include the other gender; and (vii) references to any specific Law or article,
section or other division thereof shall be deemed to include the then-current amendments thereto or
any replacement Law thereof.

17.13 No Modifications. Unless otherwise specified herein and the Exhibits attached
hereto, nothing contained in this Agreement shall affect the rights and obligations of the Parties
under the other License Documents, and the terms and conditions of all such agreements shall
remain in full force and effect.

 

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17.14 Entire Agreement. This Agreement and the Exhibits and Schedules attached hereto
constitute the entire understanding between the Parties relating to the subject matter hereof, and
no amendment or modification to this Agreement shall be valid or binding upon the Parties unless
designated as such, made in writing and signed by the representatives of such Parties

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

[The remainder of this page intentionally left blank]

 

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IN WITNESS WHEREOF, the Parties have executed and delivered this Agreement in duplicate
originals by their duly authorized representatives as of the date and year first above written.

	 	 	 
	BIOCRYST PHARMACEUTICALS, INC.

	 	SHIONOGI & CO., LTD.
	 
	 	 
	By: /s/JON P. STONEHOUSE

	 	By: /s/MOTOZO SHIONO
	Name: JON P. STONEHOUSE

	 	Name: MOTOZO SHIONO
	Title: Chief Executive Officer

	 	Title: President

 

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