Document:

Exhibit 10.67

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

 

BETWEEN:

 

HER MAJESTY THE QUEEN IN RIGHT OF CANADA,

as represented by the Minister of Health,

acting through the Public Health Agency of Canada

 

(“Canada”)

 

AND:

 

BIOPROTECTION SYSTEMS CORPORATION,
  a company incorporated as a subchapter C corporation
 under the laws of Delaware, having its registered office at
 Iowa State University Research Park,
 2901 South Loop Drive, Suite 3360, Ames, Iowa, USA 50010

 

(“Company”)

 

INTRODUCTION:

 

A.                                   WHEREAS Canada is one of the major performers in Canada of vaccine research relating to viral hemorrhagic fever (“VHF”) viruses;

 

B.                                     WHEREAS Canada has developed the technology known as the “Recombinant vesicular stomatitis virus vaccine for viral hemorrhagic fevers”;

 

C.                                     WHEREAS the main features of the technology include  [*];

 

D.                                    WHEREAS the Company has requested a license from Canada to develop and Commercialize the technology;

 

E.                                      WHEREAS Canada is willing to grant to the Company a license to develop and Commercialize the technology on the terms and conditions set out in this License Agreement;

 

F.                                      WHEREAS the fundamental principles underlying this License Agreement are that:

 

i)                                         Canada surrenders its commercial self-interest to the Company; and

 

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ii)                                      In exchange, in good faith, the Company uses its discretion and experience in product development and regulatory affairs, its commercial resources and business savvy and, assuming that any relevant statutory, regulatory or administrative authorizations or permits for a vaccine product are obtained, its marketing, sale and distribution savvy for the benefit of both Parties.

 

G.                                     WHEREAS the salient elements of this License Agreement are:

 

i)                                         Canada grants to the Company sole, worldwide, revocable and royalty-bearing license to make, use, improve, develop and Commercialize the technology in the field of prevention and prophylaxis against and treatment of VHF viruses in humans, whether before or after exposure;

 

ii)                                      Canada will retain non-commercial rights in the technology, including rights to use and further develop the technology for educational and research purposes;

 

iii)                                   The Company grants to Canada a non-exclusive and royalty-free license to make, use, manufacture and sell the VHF vaccine products developed by the Company in the exercise of the Licensed Rights, in the event of a public health emergency:

 

iv)                                  The Company will make good faith efforts to collaborate with Canada on  [*] of the Company’s basic research and development activities related to VHF virus vaccines; and

 

v)                                     The Parties agree to maintain the confidentiality of each other’s Confidential Information provided under this License Agreement.

 

H.                                    WHEREAS the expectations of the Parties are that the Company will use commercially reasonable efforts to develop a VHF vaccine and, assuming that any relevant and necessary statutory, regulatory and administrative authorizations or permits that may be required for a vaccine product are obtained, Commercialize it; and

 

I.                                         WHEREAS the Parties have agreed to their commercial relationship on the terms and conditions set out in this License Agreement.

 

NOW THEREFORE in consideration of the premises, the terms and conditions hereinafter contained and other good and valuable consideration, the receipt of which is hereby acknowledged by each party, the Parties hereto covenant and agree as follows:

 

1.0 DEFINITIONS

 

1.1                               “Affiliate”

 

means any corporation, subsidiary, partnership or other entity which the Company, directly or indirectly, controls (or has common control of) or which, directly or indirectly, controls the Company:

 

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1.1.1                        through the ownership of more than 50% of the voting share capital, and the votes attached to those securities are sufficient, if exercised, to elect a majority of the directors of the body corporate; or

 

1.1.2                        otherwise has the possession, direct or indirect, of the powers to direct or cause the direction of the management or policies of a person or entity; whether through ownership of equity participation, voting securities, or beneficial interests; by contract, by agreement, or otherwise.

 

Identified in appendix D (“Affiliates”) are the Affiliates of the Company In existence on the Execution Date.

 

1.2                               “Commercialization” or “Commercialize”

 

means:

 

1.2.1                        the commercial making, using, Sale or offering to sell;

 

1.2.2                        of the products resulting from the exercise of the Licensed Rights;

 

1.2.3                        by the Company, its Affiliates or its sub-licensees;

 

1.2.4                        in the Territory;

 

1.2.5                        within the Field of Use; and

 

1.2.6                        for the maximum commercial return to the Company and Canada in accordance with Article 4 (Exploitation of Licensed Rights) including:

 

1.2.6.2                                       the Company obtaining any statutory, regulatory or administrative authorizations or permits that may be required in order for the Company to legally carry out all of its activities under the License Agreement.

 

1.3                               “Confidential Information”

 

means, with respect to a Party, all proprietary information of any type, or any part or portion thereof, that is disclosed by that Party to the other Party pursuant to this License Agreement, whether or not such information is specifically marked or identified as confidential at the time of disclosure, which may include without limitation.

 

1.3.1                        all scientific, technical, business, financial, legal, marketing or strategic information (including trade secrets and proprietary know-how);

 

1.3.2                        all documented research, development, demonstration or engineering work, information that can be or is used to define a design or process or procure, produce, support or operate material and equipment, methods of production, regardless of its form:

 

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1.3.3                        all drawings, blueprints, patterns, plans, flow-charts, equipment, parts lists, software and procedures, specifications formulae, designs, technical data, descriptions, related instruction manuals, records and procedures;

 

1.3.4                        information that is non-public, confidential, privileged or proprietary in nature.

 

which may have actual or potential economic value in part from not being known and may be positive (what works) or negative (what does not) information;

 

1.3.5                        however fixed, stored, expressed or embodied (and includes, without limitation, samples, prototypes, specimens and derivatives);

 

1.3.6                        and including information disclosed during discussions, meetings, tests, demonstrations, correspondence or otherwise.

 

1.4                               “Confidentiality Agreements”

 

means the agreements previously executed between the Parties on the 1st day of May, 2007, November 1, 2008, and the amending letter of April 14, 2010 respectively, and contained in Appendix B (Confidentiality Agreements).

 

1.5                               “Dispute”

 

for purposes of Article 16 (Alternate Dispute Resolution (ADR)), and paragraph 17.17 (Forum Conveniens)

 

1.5.1                        includes without limitation any controversy, conflict, claim, disagreement or difference of opinion arising out of the License Agreement, (irrespective of whether it is premised on contract, tort or trust / equity), including, without limitation, any issues concerning the breach, interpretation, rectification, termination, performance, enforcement or validity of the License Agreement or the rights and liabilities of the Parties in relation to the License Agreement;

 

1.5.2                        irrespective of the fact that there is no arguable defence under the License Agreement, or that the facts or law are undisputable and subject to judicial summary proceedings;

 

but Dispute does not encompass

 

1.5.3                        any controversy, conflict, claim, disagreement or difference of opinion or the rights and liabilities of the Parties

 

1.5.3.2                                       under any collateral or antecedent agreements independent of the License Agreement; or

 

1.5.3.3                                       with any emanation of Her Majesty the Queen in Right of Canada, other than the Public Health Agency of Canada.

 

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1.6                               “Execution Date”

 

means the date on which the last signature is affixed to this License Agreement.

 

1.7                               “Field of Use”

 

means the application and use of the Licensed Rights only with products to be sold or used by the Company, or its Affiliates or sublicensees or marketed through specified trade channels in the field of prevention and prophylaxis against and treatment of VHF viruses in humans and for no other purposes whatsoever.

 

1.8                               “Generally Accepted Accounted Principles (GAAP)”

 

means, at any time, accounting principles generally accepted in Canada as recommended in the Handbook of the Canadian Institute of Chartered Accountants at the relevant time, applied on a consistent basis (except for necessary or advisable changes in accordance with the promulgations of the Canadian Institute of Chartered Accountants).  If and when Canadian GAAP does not address an accounting issue, then generally accepted accounting principles in the United States will apply.

 

1.9                               “Improvement(s)”

 

means any modification, improvement, enhancement, variation, refinement, derivative or development relating to the Licensed Rights which

 

1.9.1                        infringes any one or more claims of any of the Patents; or

 

1.9.2                        constitutes a technological advance of any degree using any of the Patents or Confidential Information (irrespective of whether it infringes one or more claims of the Patents); and

 

1.9.3                        was made and reduced into practice during the term of the License Agreement or within 12 (twelve) months of its termination or expiration by either Party; and

 

1.9.4                        when applicable, Canada is lawfully entitled to communicate and license to the Company without breaching any restrictions on use or disclosure to third parties.

 

1.10                        “Intellectual Property”

 

means, as of the Execution Date, all Patents, trade-marks, copyrights, industrial designs, trade-names, trade secrets, Confidential Information and other intellectual property rights whether registered or not, whether proprietary or not

 

i)                               owned by or licensed to Canada, relating to the Licensed Rights; or

 

ii)                            owned by or licensed to the Company, relating to the Improvements made by the Company, its Affiliates or sub-licensees,

 

as the case may be.

 

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1.11                        “License Agreement”

 

means this agreement and including all attached appendices and future amendments, and refers to the whole of this agreement, not to any particular section or portion thereof.

 

1.12                        “Licensed Product(s)”

 

means any product resulting from Commercialization under this License Agreement.

 

1.13                        “Licensed Rights”

 

means the exercise, as of the Execution Date, in whole or in part, of

 

1.13.1                                          the Patents; and

 

1.13.2                                          related Intellectual Property and Confidential Information and any subsequent changes thereto that are expressly incorporated into the License Agreement,

 

within the Field of Use as listed in Appendix A (Description of the Licensed Rights).

 

1.14                        “Party”

 

means any one of the signatories to the License Agreement and “Parties” means both of them.

 

1.15                        “Patents”

 

means

 

1.15.1                                          the patents and patent applications as listed in Appendix A (Description of the Licensed Rights);

 

1.15.2                                          any author certificates, inventor certificates, utility certificates, improvement patents and models and certificates of addition, and includes any divisions, reissues, renewals, reexaminations and extensions thereof, and all continuations, continuations-in-part and divisionals of the applications for such patents, continuations, continuations-in-part, extensions, re-issues thereof for such patents, including, but not limited to, those patents listed in “Appendix A” and any subsequent patents whose priorities are derived from any patents listed in Appendix A; and

 

1.15.3                                          subsequently patented Improvements to Patents.

 

1.16                        “Sale”

 

means without limitation the act of transferring (conditionally or unconditionally, permanently or temporarily) the results of the exercise of the Licensed Rights for consideration including but not limited to sale, lease, gift, barter, exchange or other

 

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disposition for value.  (For greater clarity any internal corporate use / consumption whatsoever of the Licensed Rights by the Company or an Affiliate or sublicensee shall be deemed a Sale at the Sales Price at the lime of the use / consumption or allocation for internal use / consumption, whichever is the earlier).

 

1.17                        “Sales Price”

 

means the aggregate gross price paid by an arm’s length purchaser or lessee for any of the results of the exercise of the Licensed Rights sold or leased by the Company without deduction, rebate or pass throughs.  If the gross price is less than the fair market value, then, for royalty calculation purposes, the gross price shall be the fair market value as set by Canada in its unfettered discretion.

 

1.18                        “Taxes”

 

means taxes (including, without limitation, sates taxes, goods & services taxes, value added taxes, however described), levies, imposts, deductions, charges, license and registration fees, assessments, withholdings / withholding taxes and duties imposed by any jurisdiction or authority (including stamp and transaction taxes and duties) together with any related interest, penalties, fines and expenses in connection with them.

 

1.19                        “Territory”

 

means the entire world, always subject to:

 

1.19.1                                the United Nations Act, R.S.C. 1985, Chap. U-2:

1.19.2                                the Export & Import Permits Act, R.S.C. 1985;

1.19.3                                Chap. E-19, Special Economic Measures Act, S.C. 1992, Chap. 17;

1.19.4                                Foreign Extra-Territorial Measures Act, R.S.C. 1985 c. F-29; and

1.19.5                                any other pertinent Canadian statutory or regulatory strictures.

 

For greater clarity Territory means all countries and jurisdictions of the world.

 

1.20                        “VHF”

 

means viral hemorrhagic fevers.

 

2.0 GRANT & RESERVATIONS

 

2.1                               Grant:

 

Subject to:

 

2.1.1                        the definitions, terms and conditions of the License Agreement,

 

2.1.2                        the Company complying with and not being in breach of any of the provisions of the License Agreement, and

 

2.1.3                        any third party peremptory rights,

 

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Canada hereby grants to the Company a personal, non-transferable, sole, revocable, royalty-bearing license for Commercialization.

 

Nothing herein shall constitute in any manner whatsoever:

 

2.1.4                        an assignment or other transfer of proprietary rights in the Licensed Rights to the Company; or

 

2.1.5                        any authorization or permission beyond that expressly given in this License Agreement.

 

2.2                               Carve Out

 

Notwithstanding anything to the contrary in the License Agreement, Canada retains from the License Agreement, any and all absolute and unfettered rights necessary to do the following:

 

2.2.1                        improve the Licensed Rights or Patents;

 

2.2.2                        to carry out educational activities;

 

2.2.3                        to pursue research and development, directly or indirectly, related to the Licensed Rights or Patents with or without the Company, collaborators or sponsors, with all attendant rights of publication;

 

2.2.4                        to make, have made, manufacture, use, license sell and distribute and to administer (directly or through health care providers) to Canadians products resulting from the exercise of the Licensed Rights, the Patents and the Improvements in the event of a public health emergency pertaining or related to VHF in Canada, for the purpose of prevention or treatment of VHF, where:

 

2.2.4.2                             the Company has not obtained regulatory approval of its product(s) under the Food and Drugs Act of Canada at the time the emergency is identified by Canada; or

 

2.2.4.3                             the Company is not able to satisfy the demand for its approved product(s) in Canada at the time the emergency is identified by Canada;

 

2.2.5                        to make, have made, manufacture, use and distribute and to administer to Canada’s staff products resulting from the exercise of the Licensed Rights, the Patents and the Improvements, for the purpose of prevention and treatment of VHF, whether in or outside a public health emergency in Canada or abroad, and

 

2.2.6                        to make, have made, manufacture, use, license, sell and distribute and to administer (directly or through health care providers) products resulting from the exercise of the Licensed Rights, the Patents and the Improvements, outside of

 

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Canada, for compassionate care purposes for the prevention or treatment of VHF, where:

 

2.2.6.2                             the Company has not obtained regulatory approval of its product(s) under the laws of the foreign country in question at the time the compassion care is identified by Canada; or

 

2.2.6.3                             the Company is not able to satisfy the demand for its approved products) in the foreign country in question at the time the compassionate care is identified by Canada.

 

2.3                               Non Compete by Canada

 

Subject to clause 2.2, Canada shall not commercially compete with the Company, or grant a license to any third party for commercial purposes, within the Field of Use concerning the Licensed Rights in the Territory.

 

2.4                               Sublicensing Permitted

 

The Company is permitted to sub-license Affiliates and non-affiliated or non-controlled parties, on the same terms and conditions of this License Agreement.  The Company has no right to encumber any contractual, legal or equitable rights the Company may have against any Affiliate or sub-licensee in favour of any financial institution or any third party whatsoever.

 

2.5                               Sublicensing Conditions

 

Any sub-license or any amendment to any sub-license granted by the Company to Affiliates and non-affiliated or non-controlled parties, shall:

 

2.5.1                        be royalty-bearing, revocable, without the right to sub-sub-license, except with the prior written consent of Canada, which consent shall not be unreasonably withheld;

 

2.5.2                        carry a royalty rate no less than that prescribed in the License Agreement;

 

2.5.3                        be only within the Territory or any portion thereof;

 

2.5.4                        be only within the Field of Use or a subset thereof;

 

2.5.5                        be subject to the same obligations and restrictions as those required of the Company under the License Agreement;

 

2.5.6                        be copied to Canada immediately following execution; and

 

2.5.7                        not be a de facto assignment.

 

For greater clarity, Canada shall receive from the Affiliates and sub-licensees not less than the same amount of consideration Canada would have received from the Company,

 

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had the Company conducted the Commercialization rather than the Affiliates or sub-licensees.  The Company shall ensure that any monies owing to Canada from the Affiliates or sub-licensees are paid to Canada when due, and shall be liable for any such monies irrespective of whether or not the Affiliate or sub-licensee paid the Company.

 

2.6                               Sub-Licensee Consideration

 

In addition to the royalties payable by the Affiliates and sub-licensees to Canada as contemplated in paragraph 2.5 (Sub-licensing Conditions), the Company shall also pay to Canada  [*]  paid by the Affiliates and sub-licensees to the Company.

 

2.7                               Termination

 

Termination of the License Agreement shall also terminate any subsisting sub-licenses, but any consideration due or owing to Canada shall be paid promptly thereafter, and any and all unsatisfied obligations and rights shall subsist until satisfied.

 

3.0 TERM

 

3.1                               Term

 

This License Agreement shall commence on the Execution Date and shall continue in force until the expiry of the last to expire of the Patents included in the Licensed Rights, subject to:

 

3.1.1                        early termination as prescribed under Article 15.0 (Termination); and

 

3.1.2                        condition subsequent in paragraph 4.1 (Business Plan).

 

4.0 EXPLOITATION OF LICENSED RIGHTS

 

4.1                               Business Plan

 

The Company shall submit a business plan to Canada within thirty (30) days of the Execution Date.  Canada shall have the right to request amendments to the business plan in order to ensure maximum commercial return to the Company and Canada in accordance with this Article 4 (Exploitation of Licensed Rights).  Once Canada has accepted the business plan, the plan is then Appendix C (Business Plan) and all the Company’s representations and statements in the plan are incorporated into the License Agreement.

 

4.2                               Disclosure Requirements

 

The business plan shall provide sufficient detail to show how the Company plans to diligently research, develop and promote and make commercially reasonable efforts to Commercialize.  This business plan shall also disclose any

 

4.2.1                        distribution and agency arrangements contemplated by the Company;

 

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4.2.2                        market studies pertinent to the Licensed Rights;

 

4.2.3                        pro forma financial statements of sufficient detail to allow a thorough financial analysis of the Company’s assumptions, projected revenue streams and costs.

 

4.3                               Continuing Disclosure

 

During the term of the License Agreement, the Company shall promptly provide to Canada any amendments or updates to the business plan.

 

4.4                               Inducement

 

The Company acknowledges that the business plan as orally presented to Canada in a pre-contractual setting, and subsequently manifested in the written format under paragraph 4.1, as accepted by Canada is the major inducement for Canada to enter into the License Agreement on the terms and conditions prescribed herein.

 

4.5                               Breach

 

If the Company

 

4.5.1                        commits a misrepresentation, omission, concealment or incorrect statement of a material fact in the negotiations leading to the License Agreement in general or leading to or in the business plan in particular; or

 

4.5.2                        breaches any representations or statements in the business plan,

 

then such failure is a material breach of the License Agreement which provides Canada with the discretionary election either to:

 

4.5.3                        rescind the License Agreement and seek damages; or

 

4.5.4                        maintain the License Agreement and seek damages alone.

 

4.6                               Commercially Reasonable Efforts to Commercialize

 

As an inducement to Canada to enter into the License Agreement, during the term (or the renewal) of the License Agreement, the Company shall:

 

4.6.1                        use commercially reasonable efforts to Commercialize;

 

4.6.2                        use commercially reasonable efforts to create and satisfy demand for the Licensed Rights; and

 

4.6.3                        not do, or assist anyone to do, anything inimical to the Commercialization.

 

Payment of fees and royalties under Article 5 (Fees & Royalties) does not relieve the Company of its obligation under paragraph 4.6 (Commercially Reasonable Efforts to Commercialize).

 

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4.7                               Shelving a Fundamental Breach

 

Any “parking”, “shelving” or other activity or inactivity concerning the Licensed Rights whereby the Company is not using its commercially reasonable efforts to diligently and aggressively Commercialize the Licensed Rights in the Territory, is a fundamental breach of the License Agreement.

 

4.8                               Research Support Collaboration

 

In carrying out basic research and development activities concerning the Licensed Rights and VHF vaccine during the term of this License Agreement, and any renewal thereof, the Company shall make good faith efforts to collaborate with Canada on [*]  of such activities, under collaborative research agreements containing commercially reasonable terms and conditions as agreed to by the Parties at that time.  Any payments made by the Company pursuant to such collaborations shall not diminish or affect the Company’s obligation to pay fees and royalties under Article 5 (Fee and Royalties).

 

5.0 FEES AND ROYALTIES

 

5.1                               Fees

 

The Company shall pay to Canada the following non-refundable lump sums:

 

5.1.1                        PATENT FEES

[*], payable within thirty (30) calendar days of the Execution Date, as a reimbursement of Patent costs incurred by Canada to date;

 

5.1.2                        SIGNING FEE

[*], payable upon signing, as a non-creditable and non-refundable signing fee in consideration of the execution of the License Agreement;

 

5.1.3                        MILESTONE FEES [*] lump sum payable on the earlier of [*] or [*] years of the Execution Date, whichever comes first;

5.1.4                        MILESTONE FEES [*] lump sum payable on the earlier of [*] or [*] years of the Execution Date, whichever comes first;

5.1.5                        MILESTONE FEES [*] lump sum payable on the earlier of [*]or [*] years of the Execution Date, whichever comes first;

5.1.6                        MILEPOST FEES [*] lump sum payable on the earlier of [*] or [*] of the Execution Date, whichever comes first.

 

5.2                               Royalty Percentage Rate

 

The Company shall pay to Canada a royalty rate of [*] of the Sales Price of Licensed Products sold by the Company, its Affiliate(s) or sublicensees.

 

5.2.1                        The royalty rate shall be lowered to [*] if:  a) an additional technology is required to Commercialize; and b) the additional technology is actually licensed by the Company from a third party and the latter actually charges royalties to the

 

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Company for such a license (as shown by documentation sufficient to establish the requirement and the actual license).

 

5.2.2                        The rate shall be towered to [*] if:  a) two (2) or more additional technologies are required to Commercialize; and b) the additional technologies are actually licensed by the Company from one or more third parties and the latter actually charge royalties to the Company for such a license (as shown by documentation sufficient to establish the requirement and the actual license).

 

5.3                               Minimum Royalty

 

Notwithstanding any other provision of the License Agreement, the Company shall pay to Canada a minimum annual royalty of  [*], payable on or before January during each year of the License Agreement.  Such amounts paid shall be creditable against royalties owed under clause 5.2 (Royalty Percentage Rate) and sub-license payments owed under clause 5.4 (Sub-Licensing Consideration) in the same year.

 

5.4                               Sub-Licensing Consideration

 

The Company shall pay to Canada  [*]  paid by the Affiliates and the sublicensees to the Company.  Such payments shall be over and above the royalty rate paragraph 5.2 (Royalty Percentage Rate) (whether or not such consideration was directly, indirectly or derivatively paid or provided) including without limitation any equity.

 

5.5                               Sub-Licensee’s Fees

 

5.5.1        COLLECTION AND ENFORCEMENT BY THE COMPANY

 

The Company shall ensure that royalties payable to Canada from Affiliates and sub-licensees shall be remitted directly to the Receiver General for Canada, at the address provided in Article 20.1 (Notice).  The Company shall take any necessary actions (at the Company’s own cost) to collect, enforce and remit royalties or other consideration owing to Canada by the Affiliates and sub-licensees.

 

5.5.2        SUB-LICENSEE’S ARREARS PAID BY THE COMPANY

 

If an Affiliate or sub-licensee has royalties or other consideration owing to Canada under a sub-license for a period in excess of thirty (30) days, then the Company shall pay to Canada that amount owing within the next fourteen (14) days immediately following the aforementioned thirty (30) days.

 

5.6                               Taxes

 

The Company shall pay Taxes at the applicable prevailing rates exigible on the Company’s activities under the License Agreement, including without limitation Commercialization or on the payment of royalties, including any withholding taxes that in the first instance are levied against Canada

 

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5.7                               Payment to Canada

 

Unless the License Agreement expressly provides otherwise, the Company shall pay any and all monies and consideration owing to Canada as follows:

 

5.7.1        TIME & MODE

 

quarterly, by cheque or money order, commencing on December 31, 2010 and thereafter on March 31, June 30, September 30 and December 31 of each year of this License Agreement;

 

5.7.2        CURRENCY & ADDRESS

 

except for royalties generated from Commercialization within Canada, cheques for the payment of royalties shall be in U.S. funds (at the conversion rate stated in the Wall Street Journal on the day prior to the date payment is due) and made payable to the “Receiver General for Canada”.  The cheque(s) shall be sent to

 

Director, Intellectual Property Management & Business Development Public Health Agency of Canada

1015 Arlington Street, Suite 2420

Winnipeg, Manitoba, Canada

R3E 3R2;

 

5.7.3        ACCOMPANYING DOCUMENTATION

 

each cheque shall be accompanied by a statement bearing the name / identification of this License Agreement and the Licensed Rights, and showing the period covered, the total sales, per country sales, the per country royalty applicable and the total royalty paid or consideration paid, as applicable.

 

5.8                               Payments to Canada after Termination

 

The Company shall pay to Canada any consideration due and payable under the License Agreement, whether incurred before termination or after, in accordance with Article 15 (Termination).

 

5.9                               Payment after Expiry of Patents

 

The Company shall continue paying the amounts as prescribed in this Article, notwithstanding any impeachment proceedings, or the expiry, expungement or other nullification of the Patents.

 

5.10                        No Set-off

 

Notwithstanding any other provision of the License Agreement, any consideration payable to Canada by the Company under the License Agreement is unconditional and

 

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non-cancelable.  Further, the Company shall not have the right of set-off, deduct or counter-claim against any such consideration.

 

5.11                        Accounting Approach

 

5.11.1                                          GAAP

 

The Company shall use GAAP in the calculation of consideration owing to Canada.

 

5.11.2                                          ACCRUAL

 

Royalties accrue on receipt of payment by the Company (or Affiliates or the sub-licensees) for the Licensed Rights.

 

5.11.3                                          INTEREST OF OVERDUE ACCOUNTS

 

In the event the Company fails to make any payment under the License Agreement when due and payable, then interest on any unpaid amount shall accrue at a rate of four (4)% above the base rate of the Bank of Montreal, Toronto, from time to time in force during the period of non-payment.

 

5.11.4                                          OTHER BASIS FOR PAYMENTS

 

If the Company receives any lump sum or other payments, royalties (including royalty payments received from third parties), or any other income or consideration for, or in respect of the Commercialization of the Licensed Rights, then the Company shall include such additional income in calculating the Sales Price.

 

6.0 RECORDS AND AUDIT

 

6.1                               Records Maintenance

 

The Company shall keep true and accurate records and maintain such records relating to Commercialization and all other obligations of the Company under the License Agreement during the term of the License Agreement and for ten (10) years following the termination or expiration of the License Agreement.

 

6.2                               Record Type

 

For greater clarity and without limiting the generality of the foregoing, records cited in paragraph 6.1 (Records) shall comprehensively address:

 

6.2.1                        financial, business, manufacturing and technical support, including without limitation sales reports, inventory reports, subcontractor and distributor agreements, tax returns, catalogues, price lists, shipping records, invoice registers, invoices, financial statements and ledgers; and

 

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6.2.2                        quality standards and monitoring reports and records.

 

6.3                               Records, Access to those held by Off Site Professionals

 

The Company irrevocably authorizes its independent accountants, KPMG LLP, to provide to Canada’s independent accountants any information it may have with respect to the Commercialization.

 

6.4                               Audit Document Right

 

Upon the written request of Canada and with at least fifteen (15) calendar days prior notice, the Company shall permit an independent accountant, retained by Canada, to inspect all relevant records (whether held internally by the Company or at the offices of professional advisors or elsewhere) in order to ascertain the accuracy of such royalties, reports and Commercialization efforts.  Such inspections shall be during business hours and in a manner that does not unduly disrupt the Company’s business.  The Company shall allow the accountant to make any necessary copies of the records that the independent accountant deems fit.

 

6.5                               Audit Interview Right

 

In addition to the rights in paragraph 6.4, upon the written request of Canada, the Company shall allow the independent accountant to interview key personnel of the Company.  The independent accountant, in its unfettered discretion, shall determine who the key personnel are for the purposes of the interview.  The Company acknowledges that the independent accountant may have more than one interview with key personnel

 

6.6                               Audit Confidentiality

 

The independent accountants retained by Canada shall inform Canada whether the Company has complied with its obligations under the License Agreement, including without limitation whether all royalties and consideration due and payable were paid as prescribed to Canada and marketing efforts and any inaccuracies in such payments.  Subject to the information contained in the foregoing audit reports, the independent accountants shall neither reveal to Canada any of the Company’s internal documentation or records, nor disclose any notes or copies of the Company’s records made by the independent accountants, excluding anything necessary for the report.

 

6.7                               Duration

 

The auditing and verification provisions herein shall continue for 10 years following the expiry or termination of this License Agreement.

 

6.8                               No Waiver

 

Any royalty payment or report accepted by Canada shall not constitute a waiver by or estoppel against Canada concerning the contractual right to audit the Company, and Canada shall continue to have the right to audit as prescribed in the License Agreement.

 

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Furthermore, an audit shall not preclude Canada from conducting subsequent audit or audits.

 

6.9                               Discrepancy Percentage

 

With respect to the earned royalties (paragraph 5.2, Royalty Rate, paragraph 5.4.  Sub-License Fees) in the event of any discrepancy uncovered by the audit, in excess of five percent (5.0%) of the amounts paid during the audited period, the Company shall pay forthwith to Canada both the discrepancy and the cost of the audit.  Overpayments shall be credited against the next payment due by the Company to Canada.

 

6.10                        Breach of Records Audit Article Material

 

The record and audit requirements are a material term of the License Agreement.

 

7.0 REPORTS & QUALITY CONTROL

 

7.1                               Report - Commercialization & Marketing

 

The Company shall, on or before the 45th day following each calendar quarter, during the term hereof and any renewal, submit to Canada written reports as to the Company’s activities with respect to the exercise of Licensed Rights during the preceding twelve (12) months.  Such reports shall contain:

 

7.1.1                        a description of the steps taken by the Company to develop and Commercialize and sub-license;

 

7.1.2                        a description of the marketing conditions for the products or processes created by the exercise of the Licensed Rights; and

 

7.1.3                        a report an the production, use and sales of the products or processes created by the exercise of the Licensed Rights.

 

7.2                               Report - Officer’s Certificate

 

The report from the Company shall also contain a certificate from either the CEO or CFO of the Company attesting to the fact that the Company has been using commercially reasonable efforts to develop and Commercialize the products or processes created by the exercise of the Licensed Rights and that Commercialization is a material and active element of the Company’s business.

 

7.3                               Report - Audited Statement 8 Remittances

 

In addition to the requirements of paragraphs 7.1 (Report Contents General) and paragraph 7.2 (Report - Officer’s Certificate), the report from the Company to Canada shall also contain an audited statement, which includes, without limitation:

 

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7.3.1                        an audited statement, including the amount of the products or processes created by the exercise of Licensed Rights sold by the Company and the amount of royalties or other consideration payable;

 

7.3.2                        the names and addresses of all Affiliates and sub-licensees to whom the Licensed Rights has been sub-licensed;

 

7.3.3                        a full account of all revenues generated by such Affiliates and sub-licenses, including the amount of products or processes created by the exercise of Licensed Rights sold;

 

7.3.4                        a calculation of the amount due to Canada for the royalties and consideration as stipulated herein as required under paragraphs 2.5 (Sublicensing Conditions) and paragraph 2.6 (Sub-licensee Consideration); and

 

7.3.5                        subject to paragraph 5.7 (Payment to Canada) any remittances then payable to Canada, payable to the Receiver General for Canada, of the amount of royalties or other consideration so payable.

 

7.4                               Report— Quality Control

 

In addition to the foregoing, the report shall also contain internal audit results, conducted quarterly, showing the quality standards of the products or processes created by the exercise of the Licensed Rights at all production sites and at the major sale or distribution sites.

 

7.5                               Quality Control Obligations

 

The Company shall comply with all quality requirements for the products or processes created by the exercise of the Licensed Rights that are prescribed by:

 

7.5.1                        Canada from time to time in writing; and

 

7.5.2                        any regulatory or statutory authority.

 

7.6                               Quality Control Spot Audits by Canada

 

The Company shall allow Canada to conduct spot audits of the Company production and sales sites during operating hours anywhere in the Territory to ensure compliance with the prescribed quality standards.

 

7.7                               Quality Control Spot Audits on behalf of Canada

 

Canada may ask the Company to conduct spot audits of the Company production and sales sites anywhere in the Territory and to disclose those results to Canada within 15 days of each audit.

 

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7.8                               Annual Report

 

The Company shall, on or before the 31st day of May of each calendar year, during the term hereof and any renewal, submit to Canada a copy of:

 

7.8.1                        the Company’s certified financial statements and evidence of renewal of the Company’s insurance policy under section 13 of the License Agreement;

7.8.2                        the Company’s annual reports to shareholders; and

7.8.3                        material revisions to the Company’s business plan.

 

7.9                               Annual Face-To-Face Meeting

 

The Company shall, on the 121st day of each calendar year, during the term of the License Agreement and any renewal, meet face-to-face with Canada to provide a progress report on the activities carried out by the Company under the License Agreement.

 

7.10                        Material terms

 

The reporting and quality requirements and audit rights are a material term of the License Agreement.

 

8.0 OWNERSHIP OF TECHNOLOGY / IMPROVEMENTS

 

8.1                               Canada Owns Licensed Rights

 

The Company agrees and is estopped from alleging otherwise that:

 

8.1.1                      the Licensed Rights are vested in and are the sole property of Canada;

 

8.1.2                      ownership and all rights related to, connected with, or arising out of the foregoing, including, without limitation:

 

8.1.2.2                             Patents, Intellectual Property, Confidential Information, copyright, the right to produce, publish or cause to be produced, and all published information material and documents;

 

8.1.2.3                             the right to issue a license;

 

are vested in and are the sole property of Canada, and

 

8.1.3                      the Company shall have no rights to the foregoing except as may be expressly granted under this License Agreement, and the Company shall not apply for any proprietary or other right and shall not divulge or disclose, without the prior written consent of Canada, any information, material or documents concerning the foregoing or make available in any way or use the Licensed Rights, except as expressly provided in the License Agreement.

 

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8.2                               No Impeachment

 

The Company shall neither impeach, contest or otherwise attack, directly or indirectly, the validity, enforceability or ownership of the Patents or any Intellectual Property rights held by Canada, or Canada’s right, title and interest in and to the Licensed Rights nor assist, counsel or procure any third party to do the same.

 

8.3                               Inimical Use of Confidential Information

 

The Company shall not use any Confidential Information obtained from Canada in the negotiation of the License Agreement, under due diligence searches or otherwise related to this License Agreement, in any manner that either violates the Company’s rights and obligations under the License Agreement or is inimical to the interests of Canada.

 

8.4                               Improvements - Ownership

 

Unless expressly agreed to otherwise in writing by the Parties, the ownership of any Improvement made by or on behalf of a Party shall immediately, after creation, vest exclusively in that Party.

 

8.5                               Company Improvements - Disclosure

 

The Company shall disclose to Canada forthwith all Improvements, innovations and discoveries developed or created by or on behalf of the Company, solely or jointly with others (including Affiliates and sub-licensees), which related to the Licensed Rights, together with any Intellectual Property rights residing therein.

 

8.6                               Company Improvements — License to Canada

 

The Company hereby grants to Canada a personal, non-transferable, non-exclusive, worldwide, perpetual, irrevocable, royalty-free and fully paid-up license for the Improvements (including data and reports related thereto), made by or on behalf of the Company under paragraph 8.4 (Improvements — Ownership) and disclosed to Canada under paragraph 8.5 (improvements — Disclosure) for the purposes set out in paragraph 2.2 (Carve Out).  Further, Canada may sub-license such Improvements for the purposes of carrying out the purposes set out in paragraph 2.2 (Carve Out).

 

Termination of the License Agreement shall not terminate the foregoing license to Canada or any subsisting sub-licenses.

 

9.0 DISCLAIMERS

 

9.1                               Estoppel Statement/Disclaimer of Express / Implied Warranties

 

The Company acknowledges that there is some question as to the integrity of ownership of the Licensed Rights and Patents and the Company accepts those risks.

 

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The Licensed Rights and Patents are provided to the Company on an “as is” basis.  Canada makes no warranties, representations or conditions, express or implied, of any nature, and Canada disclaims all warranties, representations or conditions, for the Licensed Rights, the Patents, the Intellectual Property or the Confidential Information including, without limitation:

 

9.1.1        merchantability;

9.1.2        quality (either as discussed or with respect to a sample / model);

9.1.3        fitness for any or a particular purpose:

9.1.4        commercial utility or practical purpose;

9.1.5        susceptibility of yielding valuable results or results are free of defects or otherwise harmless;

9.1.6        latent or other defects;

9.1.7        infringement or non-infringement of Patents or other third party rights;

9.1.8        conformity with the laws of any jurisdictions; or

9.1.9        fitness for the Company’s corporate objectives (whether or not expressly or implicitly communicated to Canada).

 

For greater certainty, no information or advice given by Canada shall create a warranty or representation or condition other than as expressly stated in the License Agreement.  The Company hereby accepts the Licensed Rights and the Patents “as is”, with all faults, and the entire risk as to satisfactory quality, performance, accuracy and effort is with the Company.  In no event shall Canada be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services, loss of use, data or profits, or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the exercise of the Licensed Rights by the Company, its Affiliates or sub-licensees, even if advised of the possibility of such damage.

 

9.2                               Disclaimer of Statutorily Implied Warranties

 

No legal or equitable warranties or conditions implied by law or convention under any domestic, foreign or international legal regime, or from a course of dealing or usage of trade, shall apply to the License Agreement.  The Company acknowledges this disclaimer and is estopped from relying on any such representations, warranties or conditions against Canada.

 

9.3                               Confidential Information Without Warranty / No Reliance

 

The Company shall not rely in any way on the quality, accuracy or completeness of any Confidential Information provided by Canada under the License Agreement.  Any use of such Confidential Information shall be at the Company’s sole risk and expense.  Any Confidential Information provided to the Company by Canada is without any warranty or guarantee or representation or warranty of any kind whatsoever other than as expressly provided herein.

 

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9.4                               No Liability to Canada from Exercise of Rights

 

The Company undertakes to use the Licensed Rights and apply Confidential Information of Canada entirely at its own risk and under its own responsibility, and that the Company will have no recourse against Canada with respect to any consequences of such application.

 

9.5                               Third Party Representations

 

The Company shall not represent to any Affiliate or sub-licensee the existence of any warranty or condition concerning the Licensed Rights.

 

9.6                               Disclosure & Due Diligence

 

The Company acknowledges that:

 

9.6.1        Canada has made full and frank disclosure of all facts the Company deemed relevant before executing the License Agreement;

 

9.6.2        The Company has conducted a due diligence search of all matters relevant to the Licensed Rights, the Patents and the License Agreement;

 

9.6.3        Canada has made all best efforts to identify the significant characteristics of the Licensed Rights and that Canada makes no representation that all the characteristics both favorable and unfavorable have been identified; and

 

9.6.4        Canada is either under no duty to warn the Company or the Company unconditionally waives any such duty, about the Licensed Rights or Commercialization.

 

10.0        PATENT PROTECTION & REGULATORY REQUIREMENTS

 

10.1                        Patent Costs

 

The Company shall pay all costs related to and maintaining Patents (and shall reimburse Canada for any of these costs that Canada may pay during any term of the License Agreement), as they are incurred, and within thirty (30) days of being invoiced for such costs.

 

10.2                        Right to Patent

 

Nothing in the License Agreement shall limit or restrict Canada from seeking to patent Improvements made by Canada.

 

10.3                        The Company Shall Obtain Regulatory Permissions

 

The Company shall use commercially reasonable efforts to obtain any authorizations, permits, certificates or other regulatory permissions which may be required in order for the Company to legally carry out all of its activities under the License Agreement,

 

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including but not limited to Commercialization, at the Company’s sole cost and expense without right of set-off.

 

10.4                        Her Majesty Not Obligated

 

Nothing in the License Agreement shall obligate any emanation of Her Majesty the Queen in Right of Canada to grant any required authorizations, permits, certificates or other regulatory permissions.  Conversely, there is no implication by the execution of the License Agreement that the Company will be granted any required authorization, permits, certificates or other regulatory permissions necessary for the effective Commercialization of the Licensed Rights.

 

11.0        CONFIDENTIALITY / FIDUCIARY OBLIGATIONS &
 EQUITABLE REMEDIES

 

11.1                        Existing Confidentiality Agreements

 

The Confidentiality Agreements entered into by the Parties on May 1, 2007, and November 1, 2008, respectively, shall end on the Execution Date of the License Agreement.  However, all rights and obligations of the Parties under the Confidentiality Agreements that expressly or by their nature survive termination of those agreements shall continue in full force and effect until they expressly or by their nature expire.

 

11.2                        Confidentiality Obligations

 

Commencing on the Execution Date of this License Agreement, Confidential Information disclosed by one Party to the other Party under this License Agreement shall be:

 

11.2.1      held in confidence and in trust by the receiving Party;

 

11.2.2      used by the receiving Party exclusively for the purposes authorized under the License Agreement and for no other purpose whatsoever;

 

11.2.3      safeguarded by the receiving Party using all reasonable measures and taking such action as may be appropriate to prevent the unauthorized access, use or disclosure of the Confidential Information; and

 

11.2.4      not disclosed to third parties without the prior written consent of the disclosing Party.

 

11.3                        No Waiver of Privilege

 

Each Party acknowledges that the Confidential Information of the disclosing Party is the property of the disclosing Party or a third party and that none of the latter intend to or do waive any rights, title or privilege they may have in respect of any of the Confidential Information.

 

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11.4                        Common Law Duty of Confidentiality

 

Nothing in this License Agreement derogates, displaces or otherwise diminishes the common law or equitable duty of confidentiality vested in the receiving Party concerning the Confidential Information.

 

11.5                        Confidentiality Exclusions

 

Article 11.2 (Confidentiality Obligations) does not apply to information which, even if it may be marked “confidential’, is not really confidential, in that

 

11.5.1      IN PUBLIC DOMAIN - the information was legally and legitimately in the public domain through no act or omission of the receiving Party at the time of disclosure by the receiving Party;

 

11.5.2      PUBLISHED - the information was legally and legitimately published or otherwise becomes part of the public domain through no act or omission of the receiving Party at the time of disclosure by the receiving Party;

 

11.5.3      ALREADY KNOWN TO THE RECEIVING PARTY - the information was already in the possession of the receiving Party at the time of disclosure and was not acquired by the receiving Party, directly or indirectly, from the disclosing Party (as shown by documentation sufficient to establish the timing of such possession), and the receiving Party is free to disclose the information to others without breaching any contractual or trust obligations or common law duties;

 

11.5.4      THIRD PARTY DISCLOSES - the information becomes available from an outside source who has a lawful and legitimate right to disclose the information to others, and the receiving Party is free to disclose the information to others without breaching any contractual or trust obligations or common law duties;

 

11.5.5      INDEPENDENTLY DEVELOPED - the information was independently developed by the receiving Party without any of the Confidential Information being reviewed or accessed by the receiving Party (as shown by documentation sufficient to establish the timing of such development); or

 

11.5.6      JUDICIAL/ADMINISTRATIVE ORDER - the information was released due to a compulsory order under a judicial process or under a compulsory regulatory (including securities) requirement, none of which was invited by, or consented to, by the receiving Party and the receiving Party made all reasonable efforts to secure a court order to limit production, use and disclosure of the information to the narrowest class practical under the circumstances.

 

11.6                        Secure Location

 

Each Party shall keep the Confidential Information of the other Party in a secure location accessible only to its employees specifically authorized to have access pursuant to this License Agreement.  Each Party shall ensure that its employees complies with the

 

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terms and conditions of this License Agreement and shall enter into agreements with such employees if necessary to give effect to this obligation.

 

11.7                        Return of Confidential Information

 

If this License Agreement expires or is terminated, the Parties shall return to each other the Confidential Information disclosed to them under this License Agreement and any notes, reports and other materials prepared by the receiving Party from the disclosing Party’s Confidential Information except that Canada shall be entitled to retain one copy of such records for the purposes of meeting Canada’s obligations under the federal laws of Canada and for the purposes of paragraph 8.6 (Improvements - License to Canada).

 

11.8                        Confidential Information is Proprietary

 

The Confidential Information of each Party is and shall remain the exclusive property of that Party or third parties and the receiving Party shall not claim any rights, title, interest or ownership in the Confidential Information.  The receiving Party shall not contest any such rights, title, interest or ownership.

 

11.9                        Legal and Equitable Remedies

 

Should a Party commit or threaten to commit a serious or material breach of its confidentiality or fiduciary obligations under this Article 11, then the other Party may pursue any and alt legal and equitable remedies, including without limitation, injunctive relief, accounting for profits, redistribution, damages, constructive trust and disgorgement.  Disgorgement means, for the purposes of the License Agreement, the ejection of all benefits gained by the receiving Party, traceable to the material breach, notwithstanding that such disgorgement may exceed the damages directly suffered by the disclosing Party or deprivation suffered by the disclosing Party for such breach.

 

11.10                 No Hiring of Canada’s Employees

 

The Company shall not:

 

11.10.1            solicit, hire, retain or secure;

 

11.10.2            directly or indirectly, including without limitation, the use of consultants, Affiliates or third parties;

 

11.10.3            any of the agents, servants or employees of Canada;

 

11.10.4            which agents, servants or employees are employed or retained in connection with, or whose responsibilities relate in whole or in part, to the Confidential Information, the Licensed Rights or the Patents; or helped produce or create the Confidential Information, the Licensed Rights or the Patents;

 

to accept employment with the Company of any of its Affiliates, unless

 

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11.10.5          Canada grants in advance its written permission to such a solicitation or the employment of such a person; or

 

11.10.6          [*]  have elapsed from the Execution Date.

 

11.11                 Exemption

 

The prohibition in paragraph 11.10 (No Hiring of Canada’s Employees) does not apply to general solicitations of employment issued by the Company and any hiring resulting from such solicitations that are:

 

11.11.1          not directed towards the employees of Canada; and

 

11.11.2          do not involve the Confidential Information, the Licensed Rights or the Patents.

 

11.12                 Contact Only Under License Agreement

 

The Parties shall have no discussions, correspondence or other contact with the other Party, its licensees, confidants or any person concerning the License Agreement, except through the designated representative of the other Party or any delegates identified in writing by the designated representative from time to time.

 

11.13                 Terms Of Agreement Confidential But Not Existence of Agreement

 

The Parties agree that terms of this License Agreement are confidential but not its existence.  The terms of this License Agreement shall not be disclosed by a Party unless disclosure is required by law or if the other Party agrees to the disclosure in writing prior to disclosure.

 

12.0        CORPORATE REPRESENTATIONS & WARRANTIES

 

12.1                        The Company Incorporated & Authorized 8 Bound

 

The Company represents and warrants to Canada that as of the Execution Date:

 

12.1.1          ABILITY

 

it can Commercialize, and the Company has or will have the necessary access to funds, resources, knowledge, facilities and personnel to perform its obligations under the License Agreement, including to use commercially reasonable efforts to Commercialize;

 

12.1.2          AUTHORIZATION

 

it is authorized and has the corporate power and authority to negotiate, execute, comply with and satisfy its obligations, without qualification, under the License Agreement;

 

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12.1.3          INCORPORATION JURISDICTION

 

it has been duly incorporated and organized under the laws of the state of Delaware and is validly existing under the laws of Iowa;

 

12.1.4          EXTRA-PROVINCIAL REGISTRATION

 

it is duly qualified, licensed or registered to carry on business in the Province or State of Delaware.

 

12.1.5          ENFORCEABLE

 

it is bound by the License Agreement, upon execution, and the License Agreement constitutes a legal, valid and binding obligation on the Company, enforceable against the Company in accordance with the terms of the License Agreement, except as those terms may be limited by applicable bankruptcy laws and general principles of equity,

 

12.1.6          LITIGATION

 

it has no knowledge of any legal proceeding or order pending against or, to the knowledge of the Company, threatened against or affecting, the Company or any of its properties or otherwise that could adversely affect or restrict the ability of the Company to consummate fully the transactions contemplated by this License Agreement (including without limitation the Commercialization) or that in any manner draws into question the validity of this License Agreement;

 

12.1.7          VERACITY OF STATEMENTS

 

no representation or warranty by the Company contained in this License Agreement and no statement contained in any certificate, schedule or other instrument furnished to Canada pursuant hereto or in connection with the transactions contemplated hereby, contains any untrue statement of a material fact or omits to state a material fact;

 

12.1.8          INCONSISTENT AGREEMENTS / OBLIGATIONS

 

it has not given any understanding, express or implied, to any third party which would:

 

12.1.8.2           preclude the Company from fulfilling its obligations under the License Agreement; or

 

12.1.8.3           cause the Company to breach an agreement with a third party;

 

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12.1.9          NO MARCH IN RIGHTS

 

it is not subject any “march in” or third party rights, (contractual or statutory, contingent or vested) which would give that third party any rights to the Licensed Rights not otherwise explicitly described in the License Agreement; and

 

12.1.10        NO BREACH OF THIRD PARTY AGREEMENTS

 

its execution of the License Agreement does not contravene its constituent documents or any law, regulation or official directive or any of its obligations or undertakings by which it or any of its assets are bound or cause a limitation on its powers or the powers of its directors to be exceeded.

 

12.2                        Canada Authorized

 

Canada represents and warrants to the Company as of the Execution Date:

 

12.2.1      AUTHORIZATION

 

Canada has the power and authority to negotiate, execute and comply with the License Agreement, subject to all applicable laws and the royal prerogative; and

 

12.2.1.2           no further action is required by or in respect of any governmental or regulatory authority; and

 

12.2.1.3           the License Agreement is legal, binding and enforceable in accordance with its terms.

 

13.0        INDEMNITY, INSURANCE AND LIABILITY ALLOCATION & CAPS

 

13.1                        The Company’s Indemnification

 

The Company shall;

 

13.1.1      indemnify; and

 

13.1.2      save harmless;

 

Canada (and her employees, servants and agents),

 

13.1.3      from and against all claims, demands, losses, penalties, damages, costs, (including reasonable solicitor and own-client costs and expert witness costs), actions, suits or other proceedings whatsoever, whether groundless or otherwise,

 

13.1.4      brought or prosecuted in any manner which heretofore or hereafter may be made by a third party against Canada or her employees, servants and agents;

 

13.1.5      however and whenever arising out of, relating to, occasioned by or attributed to,

 

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a)                                      any acts or conduct (including, without limitation, omissions, misrepresentations, errors and offences) of the Company, its employees, servants, agents, advisors, sub-licensees or Affiliates (whether by reason of negligence or otherwise) in the performance by the Company of the provisions of the License Agreement or any activity undertaken or purported to be undertaken under the authority or pursuant to the terms of the License Agreement, including without limitation, exercise of the Licensed Rights and Commercialization;

 

b)                                     any infringement or alleged infringement by the Patents, the Licensed Rights or Licensed Products of proprietary rights of any including, without limitation, patent, trade-mark, copyright or trade secret rights;

 

c)                                      any claim the Patents, the Licensed Rights or the Licensed Products or any aspect or use thereof by the Company infringes or constitutes misappropriation of the intellectual property rights of any third party; and

 

d)                                     any claim or demand against the Patents, the Licensed Rights, the Licensed Products or the interest of Canada or the Company therein.

 

Further, the Company shall not third party Canada for any such claims, actions, suits or other proceedings taken solely against the Company and the Company hereby expressly waives any rights it has against Canada for claims of infringement.

 

13.2                        Indemnity Separate / Continuing

 

The foregoing indemnity is a continuing obligation, separate and independent from the other obligations of the Company and survives termination of, expiration of, or the acceptance of repudiation of the License Agreement.  It is not necessary for Canada to incur expense or make payment before enforcing a right of indemnity conferred hereunder.

 

13.3                        Insurance

 

The Company shall ensure that both the Company and each of its Affiliates and sub-licensees shall obtain and maintain, throughout the term of the License Agreement (and any renewal thereof) or duration of the sub-licenses (as the case may be), comprehensive general liability insurance for any and all claims, actions, liabilities and expenses resulting from the Commercialization of the License Rights.

 

13.3.1      INSURANCE COMPANY

 

The insurance policy shall be obtained from a qualified insurance company licensed to do business in the applicable jurisdictions.

 

13.3.2      NAMED INSURED

 

The insurance policy shall name Her Majesty the Queen in Right of Canada and Her employees, servants and agents as “additional insureds”.

 

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13.3.3      LIMITS

 

As of the Execution Date, the insurance policy shall include commercial general liability insurance, and shall have monetary limits in the amount not less than one million dollars ($1,000,000) for each single occurrence or claim.  Following the submission of an Investigational New Drug covering a Licensed Product and prior to the beginning of a Phase 1 Clinical Study, the insurance policy shall include commercial general liability insurance, that includes products liability insurance, and shall have monetary limits in an amount not less than five million dollars ($5,000,000) for each single occurrence or claim.  The minimum amount of insurance coverage required under this License Agreement shall not be construed as a limit of liability.

 

13.3.4      TERMINATION NOTICE

 

The insurance policy shall provide for thirty (30) business days written notice by the insurer to the Company and Canada by registered or certified mail in the event of any modification, cancellation or termination of the insurance policy.

 

13.3.5      COPY

 

The Company shall provide Canada a copy of the insurance policy not later than 30 days alter execution of the License Agreement, and thereafter upon the written request of Canada.  This obligation shall apply each time the monetary limits are increased pursuant to clause 13.3.3, in which case the copy shall be provided not later than 30 days after the monetary limits in the insurance policy are increased.  This obligation shall survive termination or expiration of the License Agreement.

 

13.3.6      INSURANCE UNAVAILABLE

 

If insurance required to meet the monetary limits in clause 13.3.3 is unavailable, the Parties shall review the situation, and Canada may elect to either allow the Company to obtain the insurance that is available, or alternatively terminate the License Agreement.

 

13.4                        Canada’s Liability Cap

 

Canada’s liability for:

 

13.4.1      breach of the representations, conditions or warranties contained herein or any of the other provisions of the License Agreement or any other breach giving rise to liability, including a breach of a condition or fundamental term or fundamental breach or breaches; or

 

13.4.2      in any other way arising out of or related to the License Agreement; or

 

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13.4.3      for any cause of action whatsoever and regardless of the form of action (including breach of contract, trust, strict liability, tort [*], or any other legal or equitable theory);

 

shall be limited to the Company’s actual direct (immediate and foreseeable at the time of negotiation to both Parties), provable damages in an amount not to exceed in the aggregate a sum equal to or less than the net consideration received by Canada from the Company under paragraph 5.2 (Royalty Percentage Rate) for the time period commencing from the Execution Date up to and including the date of judicial judgment or arbitrator’s decision.

 

13.5        Excluded Heads of Damage

 

Canada shall not be liable to the Company, its employees, servants, agents, successors, assigns, Affiliates or sub-licensees for damages in respect of:

 

13.5.1      incidental, indirect, special, punitive, exemplary damages;

 

13.5.2      any economic loss, consequential damages, relational loss, including but not limited to lost business revenue, lost profits, business interruption, failure to realize expected savings, loss of data, loss of business opportunity suffered by the Company or any claim whatsoever and whenever made against the Company by any other party;

 

(whether grounded in tort [*], strict liability, contract, trust or otherwise,) even if:

 

13.5.3      Canada was advised of the possibility of such damages, or

 

13.5.4      the damages encompassed by subparagraphs 13.5.1 and 13.5.2 were foreseeable by Canada, or

 

13.5.5      such damages resulted from a fundamental breach of the License Agreement.

 

Further, Canada shall have no duty to warn the Company for matters arising directly or indirectly under the License Agreement.

 

13.6        No Actions Against Employees

 

The Company acknowledges and estopped from and waives any rights the Company might have to commence and prosecute any action whatsoever, regardless of form or grounds (including without limitation negligence, misrepresentation, fiduciary, deceit) against any of Canada’s employees, servants, agents or officers, arising out of any

 

13.6.1      claimed breach of the License Agreement;

13.6.2      transactions under the License Agreement;

13.6.3      negotiations leading to the License Agreement; or

13.6.4      in any other way related to the License Agreement.

 

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For greater clarity, the Company’s remedies for any breach of or Dispute under the License Agreement, lies only against Canada, and only within the aforementioned parameters prescribed by the License Agreement.

 

13.7        Notifications

 

Canada shall notify the Company of any claim that falls within the parameters of the respective indemnification obligations as soon as practical.  In any case such notice shall be made forthwith upon notice that a claim may be prosecuted or a cause of action exists.

 

14.0        INFRINGEMENT

 

14.1        Third Party Suit

 

Subject to Article 13 (Indemnification), in the event of any threatened or actual suit against the Company in consequence of the exercise of any rights and licenses granted herein, the Company shall; promptly inform Canada and the Parties will Jointly decide on the steps to be taken in the circumstances.  In any event, the Company will always have the sole right to defend itself as it determines against any suit or other action brought against the Company or its employees or agents.

 

14.2        Infringement Uncovered

 

Each Party will notify the other promptly in writing when any infringement of the Licensed Rights or Patents is uncovered or suspected.

 

14.3        Company May Sue

 

The Company shall have the right to enforce the Patents against any infringement or alleged infringement thereof, and shall at all times keep Canada informed as to the status thereof.  Subject to Canada’s prior written approval (which will not be unreasonably withheld), the Company may, at its own expense, institute suit against any such infringer or alleged infringer and prosecute such suit in a manner consistent with the terms and provisions hereof.  Canada shall reasonably cooperate in any such litigation at the Company’s expense, and the Company shall keep Canada apprised in a timely manner of all litigation activities.  In any litigation under this article, the Company shall not have the right to settle or otherwise compromise Canada’s position as a licensor or owner of the Patents without Canada’s prior written consent.

 

14.4        Distribution of Company’s Recovery

 

In the event of a recovery by the Company of punitive and non-punitive damages (net of legal fees and out of pocket costs of the action) under paragraph 14.3 for royalty-bearing products, the Company shall pay to Canada [*]  of such recovery.

 

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14.5        Canada May Sue

 

If the Company elects not to enforce the Patents as to any infringement or alleged infringement thereof, then the Company shall so notify Canada in writing within one (1) month of receiving notice that an infringement exists, and Canada may, in its sole judgment and at its own expense, take steps to enforce the Patents against such infringement or alleged infringement and control, settle, and defend such suit in a manner consistent with the terms and provisions hereof, and recover for its own account any damages, awards or settlements resulting therefrom.

 

15.0        TERMINATION

 

15.1        By Canada for Cause

 

The License Agreement, at the option of Canada, without prejudice to any other rights in law of equity held by Canada (including any right of indemnity), may be terminated forthwith by Canada without compensation to the Company if:

 

15.1.1      INSUFFICIENT EFFORTS

 

The Company fails to use its commercially reasonable efforts to develop or Commercialize and does not cure such failure within ninety (90) days of written notice from Canada;

 

15.1.2      NO PAYMENT

 

The Company fails to make any payment owed to Canada under the License Agreement and does not make such payment within sixty (60) days of the due date;

 

15.1.3      BREACH OF CONFIDENTIALITY

 

The Company uses or discloses Confidential Information of Canada in a manner inconsistent with its obligations under the License Agreement or fails to safeguard the Confidential Information of Canada;

 

15.1.4      BREACH OF BUSINESS PLAN

 

The Company fails, neglects, refuses or is unable to comply with the business plan created and submitted under paragraph 4.1 (Business Plan);

 

15.1.5      QUALITY CONTROL & AUDIT

 

The Company refuses, neglects or fails to meet quality standards or allow access for quality audit purposes contrary to paragraph 7.0 (Reports & Quality Control) or provide or allow the audit of the reports and records as required under Article 6.0 (Records and Audit);

 

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15.1.6      CEASES BUSINESS

 

The Company ceases to actively carry on business;

 

15.1.7      MULTIPLE BREACHES

 

The Company breaches three or more provisions of the License Agreement within any consecutive twelve (12) month period, notwithstanding that such breaches were subsequently cured;

 

15.1.8      CROSS-DEFAULT

 

The Company breached a provision of another agreement with Canada that was executed with the Public Health Agency of Canada, and that breach occurred during the term of the License Agreement;

 

15.1.9      CRIMINAL CONVICTION

 

The Company was convicted of a criminal or regulatory offence, the nature of which directly or indirectly affects the ability of the Company to conduct itself hereunder or to Commercialize in an effective and timely manner, or otherwise prejudices Commercialization;

 

15.1.10    GENERAL BREACH

 

The Company commits or permits a breach of any of the other terms and conditions herein contained and does not remedy such breach within sixty (60) days after being required in writing to do so by Canada;

 

15.1.11      REPUDIATES

 

The Company expressly or implicitly repudiates the License Agreement by refusing or threatening to refuse to comply with any of the provisions of the License Agreement.

 

15.2        Automatic Termination

 

The License Agreement and all rights granted to the Company pursuant to the License Agreement shall immediately terminate and revert to Canada by operation of contract, without prejudice to any other rights in law of equity held by Canada (including any right of indemnity) and without compensation to the Company, effective the business day prior to the applicable triggering event, namely if:

 

15.2.1      ASSIGNMENT

 

The Company assigns the License Agreement without the prior written consent of Canada, contrary to the provisions of paragraph 18.2 (No Assignment Without Consent); or

 

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15.2.2      BANKRUPTCY

 

The Company becomes bankrupt or insolvent or otherwise

 

15.2.2.2           has a receiving or winding up order made or sought against it;

 

15.2.2.3           has a meeting proposed or convened, seeking or actually passing a resolution to appoint a trustee or official manager;

 

15.2.2.4           has a receiver, receiver-manager, liquidator, trustee in bankruptcy, custodian or any other officer with similar powers appointed for the Company or such an order is sought;

 

15.2.2.5           has any or all of its assets seized or otherwise attached for the benefit of creditors;

 

15.2.2.6           proposes or convenes a meeting to seek or passes a resolution for winding up;

 

15.2.2.7           takes the benefit of any statute, at the time in force, relating to bankrupt or insolvent debtors for the orderly payment of debts;

 

15.2.2.8           makes a general assignment for the benefit of creditors;

 

15.2.2.9           submits a proposal or arrangement under any debtor/creditor legislation;

 

15.2.2.10         is the subject of a petition or files an assignment under the Bankruptcy Act or any successor legislation; or

 

15.2.2.11         does or attempts anything analogous to the aforementioned events or having a substantially similar effect to any of the aforementioned events under the laws of any jurisdiction.

 

15.3                        Termination Not A Penalty

 

The Company acknowledges, and is estopped from alleging otherwise, that the termination provisions in paragraph 15.2 do not constitute a penalty, and are otherwise fair, just and proportional given:

 

15.3.1      the nature of the Parties;

15.3.2      their respective mandates and corporate objectives;

15.3.3      the allocation of risks under the License Agreement;

15.3.4      the goals of the Parties;

15.3.5      nature of the Licensed Rights; and

15.3.6      the consequences to Canada if the Company commits the aforementioned breaches.

 

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15.4        Procedure

 

Termination shall be implemented by a notice effective as of the date slated therein, but termination shall be subject to paragraph 15.6 (The Company’s Duties on Termination) and be without prejudice:

 

15.4.1      to the right of Canada to sue for and recover any royalties or other sums due Canada; and

 

15.4.2      to the remedy of either Party in respect of any previous breach of the License Agreement.

 

15.5        Effect on Sub-licensees

 

All sub-licenses, including those granted to Affiliates, shall terminate with the License Agreement.

 

15.6        The Company’s Duties on Termination or Expiration

 

A) Upon termination of the License Agreement by Canada, the Company shall at its own cost:

 

15.6.1              return immediately to Canada all Licensed Rights and Confidential Information of Canada, including copies thereof;

 

15.6.2              certify in writing to Canada within thirty (30) days of termination, that to the best of the Company’s knowledge, all of the Confidential Information (including copies) of Canada has been returned;

 

15.6.3              deliver a detailed statement to Canada of the inventory of the products made from the exercise of the Licensed Rights then existing, but not sold by the Company, as of the date of expiration or termination;

 

15.6.4              provide Canada the right of first refusal to purchase from the Company any products made from the exercise of the Licensed Rights inventory at fair market value;

 

15.6.5              dispose of any remaining products made from the exercise of the Licensed Rights in inventory as specified by Canada subject always to any obligations under Article 5.0 (Fees & Royalties);

 

15.6.6              pay all costs due under the License Agreement either by the Company on its behalf or a sub-licensee, up to and including the termination date, within thirty (30) days of the termination;

 

15.6.7              pay all costs due under the License Agreement, subsequent to the termination, for any products made from the exercise of the Licensed Rights sold after termination, within thirty (30) days of the liability being incurred;

 

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15.6.8              grant back to Canada any technology rights, clinical or research data arising from the Licensed Rights or otherwise under the License Agreement;

 

15.6.9              assign to Canada (or her nominee) any equities, goodwill, or other rights which the Company has or alleges to have acquired in the Licensed Rights or derived in the Commercialization.  The Company shall also execute such further documentation as Canada may reasonably request m order to confirm such assignment;

 

15.6.10            pay immediately to Canada any royalties, fees, reimbursements or other financial obligations irrespective of the fact such monies are owed, but for the termination or expiration, not yet payable; and

 

15.6.11            assign or transfer for [*] in total consideration, any and all authorizations, permits, certificates or other regulatory permissions obtained in order to Commercialize, to any third party identified by Canada or to Canada itself, within ninety (90) days of termination or expiration, unless otherwise requested by Canada.

 

B) Upon expiration of the License Agreement, the Company shall at its own cost, perform the duties set out in sections 15.6.1 to 15.6.8.  Further, upon expiration, the Company shall grant to Canada the right to exercise an option to negotiate with the Company an agreement dealing with the matters set out in sections 15.6.9 to 15.6.11.  The Parties shall negotiate the agreement in good faith.  The agreement shall contain mutually acceptable terms and conditions and the consideration shall be commercially reasonable.

 

15.7        Surviving Obligations

 

All obligations of the Parties which expressly or by their nature survive termination or expiration, shall continue in full force and effect subsequent to and notwithstanding such termination or expiration, until they are satisfied or by their nature expire.  For greater clarity, and without restricting the generality of the foregoing, the following provisions survive termination or expiration:

 

15.7.1      Paragraph 2.2 (Carve Out);

15.7.2      Article 5.0 (Fees and Royalties);

15.7.3      Article 6.0 (Records & Audit);

15.7.4      Paragraphs 8.4 to 8.6 (Improvements — Ownership, Company Improvements -Disclosure, Company Improvements - License to Canada);

15.7.5      Article 11.0 (Confidentiality / Fiduciary & Equitable Remedies);

15.7.6      Article 13.0 (Indemnity, Insurance and Liability Allocation & Caps); and

15.7.7      Paragraph 15.6 (The Company’s Duties on Termination or Expiration).

 

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16.0        ALTERNATE DISPUTE RESOLUTION (ADR)

 

16.1        Negotiations

 

16.1.1      INFORMAL NEGOTIATIONS

 

If a Dispute arises between the Parties, then:  within 6 months from when the allegedly aggrieved Party knows or should know of the Dispute, the contact individuals in Article 20.1 (Notice) shall,

 

16.1.1.2           contact their counterpart, and attempt bona fide efforts to diligently resolve the Dispute through amicable negotiations:

 

16.1.1.3           provide full, frank and timely disclosure of all relevant facts, information and documents to facilitate those negotiations;

 

16.1.1.4           resolve the Dispute within 7 days;

 

16.1.1.5           reduce the Dispute to writing, and if the contact persons cannot agree on the wording of the Dispute, both contact persons shall submit to each other their written version of the Dispute.

 

16.1.2      FORMAL NEGOTIATIONS

 

If the Parties are unable to resolve the Dispute within fourteen (14) calendar days from the receipt by the other Party of the written version of the Dispute, then within the following thirty (30) days the Dispute shall be referred to the Chief Public Health Officer, on behalf of Canada, and to the CEO, on behalf of the Company (or their directly reporting designates), to negotiate a resolution.

 

16.1.2.2           These individuals may not delegate, substitute or direct, surrogates for them at these negotiations.

 

16.1.2.3           These individuals shall meet in person to negotiate and the Parties shall bear their own costs.

 

16.1.2.4           Unless otherwise agreed, the meetings shall alternate between Company, HQ, and Canada, HO, commencing in Ottawa, Ontario, for the first meeting for the first Dispute.  There shall be one meeting only per Dispute, which meeting shall not exceed one (1) business day in length.

 

16.1.2.5           The Parties may bring no more than two consultants to a meeting.  The two consultants shall not have a right of audience or otherwise to negotiate the Dispute.

 

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16.2        Mediation

 

If, within thirty (30) days following the close of the meeting under paragraph 16.1.2 (Formal Negotiations), the Parties have not succeeded in negotiating a resolution, then the Parties shall jointly submit the Dispute to mediation.

 

16.3        Skip Mediation - Direct to Arbitration

 

If the Parties cannot agree to jointly submit the Dispute to mediation, then either Party may submit the Dispute to binding arbitration.

 

16.4        Mediation Process

 

The Parties shall

 

16.4.1      APPOINTMENT OF MEDIATOR

 

appoint a mutually acceptable mediator with sixty (60) days from the close of the formal negotiation meeting under sub-paragraph 16.1.2 (Formal Negotiations);

 

16.4.2      GOOD FAITH EFFORTS

 

participate in good faith in the mediation and negotiations related thereto;

 

16.4.3      EMPOWERED REPRESENTATIVES

 

representatives sent to the mediation shall be empowered or have sufficient delegated authority to resolve, compromise, negotiate or settle the Dispute submitted to mediation, without seeking further instructions or approvals from any superiors or committees / corporate structures, unless the nature, seriousness or financial quantum of the Dispute by law or corporate policies or practices requires approval from the respective corporate or government structure.  In such event, such approval shall be obtained within five (5) business days of the proffer of any settlement offer;

 

16.4.4      COSTS

 

bear the costs of the mediation equally, except that each Party shall bear its own personal costs of the mediation;

 

16.4.5      FULL DISCLOSURE

 

a full, frank and timely manner all relevant facts, information and documents to facilitate the mediation; and

 

16.4.6      LOCATION

 

The mediation shall take place in the city that was not the site of the formal negotiations for the Dispute.

 

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16.5        Unsuccessful Mediation —Remit to Arbitration

 

The Dispute shall be referred to binding arbitration by either or both Parties if the Parties are not successful in resolving the Dispute through mediation.

 

16.6        Arbitration - Structure

 

After negotiation and if applicable, mediation), any subsisting Dispute between the Parties, shall be referred to arbitration by a written submission signed by either Canada or the Company.

 

16.6.1      FORUM LAWS PROCEDURAL RULES

 

The arbitration tribunal shall be governed by the UN Commercial Arbitration Code, referred to in the Commercial Arbitration Act, R.S.C. 1985, c.C-34.6 (“Code”).

 

16.6.2      NUMBER OF ARBITRATORS

 

The arbitration tribunal shall consist of one arbitrator chosen by the Parties.

 

16.6.3      ISSUE BEFORE ARBITRATOR

 

The scope of the arbitration shall be limited to the resolution of the Dispute submitted to arbitration.

 

16.6.4      APPLICABLE SUBSTANTIVE LAW

 

The arbitration tribunal shall decide the Dispute (including limitations, set-off claims) in accordance with the laws in force in the Province of Ontario and any applicable federal laws.

 

16.6.5      NO EQUITY

 

The arbitration tribunal shall not be authorized to decide ex aequo et bono or as amiable compositeur.

 

16.6.6      ARBITRAL INTERIM ORDERS

 

Subject to subparagraph 16.6.5 (No Equity) the arbitration tribunal shall have all the powers of a court at law or in equity, including the power to make interim orders, orders of injunction (either mandatory or prohibitory), rectification, expungement and orders for interest.  However in no case will the final decision breach the strictures of subparagraph 16.6.5 (No Equity).

 

16.6.7      LOCATION

 

The proceedings shall take place in the city that was not the site of the mediation (or if there was no mediation, in the city that was not the site of the negotiation meeting), unless the Parties agree otherwise.

 

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16.6.8      LANGUAGE

 

The language used in the proceedings shall be English.

 

16.6.9      NOTICES

 

All written communication shall be delivered to the Parties hereto in the manner provided for in Article 20.1 (Notice).

 

16.6.10    COSTS

 

The costs of the tribunal’s fees and expenses shall be shared equally by the Parties.  The Parties shall bear their own costs except that the losing Party shall pay all costs, fees, levies and Taxes arising from and necessitated by the enforcement of the arbitration tribunal’s award, including, without limitation, registration enforcement charges or other judicial levies.

 

16.7        Emergencies / Judicial Jurisdiction

 

The Parties are not precluded from bringing an application to a Court having jurisdiction for interim or interlocutory relief, in law or in equity, including, without limitation, injunctive relief, if such relief is urgently required to preserve the rights or property of either or both of the Parties, pending the final determination of those rights in a subsequent arbitral proceeding as contemplated in this Article.

 

16.8        Final & Binding

 

Subject to the Code, the Parties hereto agree that the award and determination of the arbitration tribunal shall be:

 

16.8.1      final and binding on both Parties;

 

16.8.2      without right of appeal;

 

16.8.3      the exclusive remedy between the Parties, regarding any claims, counterclaims, issues or accountings presented or pled to the arbitration tribunal, and

 

the judgment upon the award rendered by the arbitration tribunal may be entered in any Court having jurisdiction thereof or having jurisdiction over either of the Parties.

 

16.9        Arbitral Decision Deadline

 

The arbitration tribunal retainer shall contain the obligation that the arbitration tribunal render a written decision with reasons within thirty (30) days from the close of the hearing or submission of written argument.

 

16.9.1      If the facts and law are either too complicated or voluminous to allow a properly considered decision within thirty (30) days, then the decision shall be rendered in not less than one hundred and eighty (180) days, but the arbitrator shall notify the 

 

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Parties of the longer decision period by not later than the close of final arguments.

 

16.10      Power to Settle

 

The Parties’ representatives at any arbitration throughout the arbitration shall be empowered or have sufficient delegated authority to resolve, compromise, negotiate or settle the Dispute submitted to arbitration, without seeking further instructions or approvals from any superiors or committees / corporate structures.  The representatives shall either be the same persons as in paragraph 16.1.2 (Formal Negotiations) or their immediate subordinates.

 

16.10.1            Notwithstanding the foregoing, if the nature, seriousness or financial quantum of the Dispute in law or corporate policies/practices requires approval from the Board of Directors, or the Chief Public Health Officer, as the case may be, then, such approval shall be obtained within five (5) business days of the proffer of any settlement offer.

 

16.10.2            If applicable, the arbitration tribunal shall withhold its final decision until the Parties have ceased negotiating a settlement.

 

16.11      Adjournment to Empower Representative

 

Breach of paragraph 16.10 (Power to Settle, [Duly empowered representative]), shall entitle the other Party to seek an adjournment of the arbitration proceedings, to give the breaching Party time to appoint a duly empowered representative within the thirty (30) days.  All costs directly traceable to such delay, including arbitration tribunal costs and the non-breaching Party’s costs, shall be paid forthwith by the breaching Party.

 

16.12      Deemed Abandonment

 

Failure of the breaching Party to appoint such a representative within the thirty (30) day period shall be deemed a withdrawal or abandonment of the Dispute by the breaching Party and the arbitrator shall render a formal decision, finding in favour of the non-breaching Party.

 

16.13      General ADR Conditions

 

16.13.1            NO LITIGATION

 

If either Party has submitted the Dispute to court, which Dispute should properly have been submitted for resolution by arbitration, then the court filing Party shall discontinue the court proceedings forthwith, upon notice from the other Party, and both Parties shall remit the Dispute to arbitration hereunder.

 

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16.13.2            OBLIGATIONS DURING ALTERNATE DISPUTE RESOLUTION (ADR)

 

During the progress of ADR, the Parties hereto shall continue to diligently perform their obligations under the License Agreement.

 

16.13.3            PRIVILEGE

 

Neither Party shall be required to disclose documents that are privileged or created in contemplation of litigation.  If a Party does disclose such a document during ADR, that disclosure shall not be construed as a waiver of any privilege unless the disclosing Party so elects in writing.

 

16.13.4            CONFIDENTIALITY

 

The Parties shall keep confidential the existence of the proceeding under this article, and any element of the ADR (including, without limitation, all conduct, statements, promises, offers, views, pleadings, briefs, documents, testimonies, identity of witnesses, submissions, awards and opinions, whether oral or written), made in the course of the ADR, except as may be lawfully required in judicial or regulatory proceedings relating to the arbitration or otherwise.  Without limiting the generality of the foregoing, and for greater clarity, neither Party may make any publicly accessible statements / publications nor any shareholder or press announcements concerning any element of the ADR beyond the fact of the ADR.

 

16.13.5            ADR DISCLOSURES NOT ADMISSIBLE IN SUBSEQUENT PROCEEDINGS

 

Subject to subparagraph 16.13.6 (Normally Admissible Evidence), all conduct, statements, promises, offers, views and opinions, whether oral or written, made in the course of the ADR by either Party, or the mediator or arbitrator, are not discoverable or admissible for any purposes, including impeachment, in any subsequent litigation or other proceedings involving the Parties.

 

16.13.6            NORMALLY ADMISSIBLE EVIDENCE

 

Evidence that would otherwise be discoverable or admissible and was not created for an ADR, is not excluded from discovery or admission solely as a result of its use in the ADR.

 

16.14      Limitation

 

All Disputes must be submitted to ADR within one (1) year from the time of the facts giving rise to the Dispute.  Failure to submit the Dispute within the one (1) year period means a loss of all rights to submit the Dispute to ADR or litigation.

 

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16.15      Material Breach

 

The failure, neglect or unwillingness of a Party to use or diligently participate in and prosecute a Dispute through ADR is a material breach of the License Agreement.

 

17.0        INTENT AND INTERPRETATION

 

17.1        Entire Agreement

 

The License Agreement constitutes the entire and exclusive agreement between the Parties pertaining to the Commercialization and licensing and supersedes all prior agreements, conditions, obligations, understandings, and negotiations both written and oral.  The License Agreement sets forth all obligations, undertakings, conditions, representations and warranties forming part of, or in any way affecting or relating to the Commercialization.  The Parties acknowledge that with respect to the Commercialization there are no agreements, obligations, undertakings, representations or warranties whether collateral, oral or written, between the Company and Canada other than those expressly set out in the License Agreement.

 

17.2        No Third Parties

 

Neither the License Agreement or any provision thereof is intended to confer upon any person other than the Parties, any rights or remedies hereunder.

 

17.3        No Pre-Contractual Inducing Representations

 

The License Agreement supersedes and revokes all negotiations, arrangements, letters of intent, offers, proposals, brochures, term sheets, representations, memoranda of understandings and information conveyed, whether oral or in writing or electronically,  between the Parties, or any other person purporting to represent the Company or Canada.  Each of the Parties agrees that:

 

17.3.1          neither has been induced to enter into the License Agreement by any representations whatsoever not set expressly forth in the License Agreement;

 

17.3.2          neither has relied on any such representations;

 

17.3.3          no such representations shall be used in the interpretation or construction of the License Agreement; and

 

17.3.4          no claims (including, without limitation, loss of profits, indirect, incidental, consequential damages and economic loss) arising directly or indirectly, from any such representation, negligent or otherwise, shall accrue in law or equity, or be pursued by the Company, and Canada shall have no liability for any such claims.

 

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17.4        Due Diligence Search

 

The Company agrees that it has conducted its own due diligence examinations in order to satisfy itself of the full, true and plain disclosure of all facts pertinent to the Licensed Rights and all representations made by Canada.

 

17.5        Independent Legal Advice

 

It is acknowledged by the Parties that each has had legal advice to the full extent deemed necessary by each Party.  Furthermore, the Parties acknowledge that neither acted under any duress in negotiating, drafting and executing the License Agreement.

 

17.6        No Adverse Presumption in Case of Ambiguity

 

There shall be no presumption that any ambiguity in the License Agreement be resolved in favour of either of the Parties.  For greater certainty, the contra proferentum rule shall not be applied in any interpretation of the License Agreement.

 

17.7        Severability

 

If a jurisdiction declares, finds or holds any part of the License Agreement invalid, void, unenforceable or contrary to public policy for any other reason, then:

 

17.7.1          NON-MATERIAL

 

if the invalid provision is not material or fundamental to the License Agreement, the invalid provision shall not affect the validity of the remainder which remainder shall continue if full force and effect and be construed as if the License Agreement had been executed without the invalid provision in that jurisdiction only;

 

17.7.2          MATERIAL

 

if the invalid provision is material to the License Agreement then that provision shall be “read down” or replaced with a provision which accomplishes, to such extent as is possible, the original legal and business purpose of such provision in a valid and enforceable manner, in that jurisdiction and the remainder of the License Agreement shall remain binding on the Parties; and

 

17.7.3          FUNDAMENTAL

 

if the invalid provision is fundamental to the License Agreement, including any of the elements of a bare license, then:

 

17.7.3.2       the jurisdiction which found the invalidity shall be deleted from the Territory; or

 

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17.7.3.3       if the jurisdiction cannot be deleted from the Territory, or there is more than one jurisdiction, then the License Agreement shall terminate.

 

17.8        Successors and Assigns

 

The License Agreement will be for the benefit of and be binding upon the heirs, executors, administrators, permitted successors, permitted assigns, and permitted Affiliates of the Company and other legal representatives, as the case may be, of each of the Parties.  Every reference in the License Agreement to any Party includes the heirs, executors, permitted administrators, permitted successors, permitted assigns, and Affiliates and other permitted legal representatives of the Party.

 

17.9        Plurality and Gender

 

Reference to a Party will be read as if all required changes in the singular and plural and all grammatical changes rendered necessary by gender had been made.

 

17.10      Not a Joint Venture

 

The Parties expressly disclaim any intention to create a partnership, joint venture or joint enterprise.  The Parties acknowledge and agree that:

 

17.10.1            nothing contained in the License Agreement nor any acts of any Party shall constitute or be deemed to constitute the Parties as partners, joint venturers or principal and agent in any way or for any purpose;

 

17.10.2            no Party has the authority to act for, or to assume any obligation or responsibility on behalf of any other Party; and

 

17.10.3            the relationship between the Parties is that of licensor and licencee.

 

17.11      Minister Not Fettered

 

Nothing in the License Agreement shall derogate or otherwise fetter the ability of Canada to regulate, administer, manage or otherwise deal with public health and all attendant matters thereto.

 

17.12      Federal Legislation

 

The application to the License Agreement of any Federal act or regulation includes any subsequent amendment, revision, substitution, consolidation to that act or regulation, notwithstanding that such amendment, revision or substitution occurred after the execution of the License Agreement or may have a retroactive effect.

 

17.13      Right to Legislate

 

Nothing in the License Agreement shall prohibit, restrict or affect the right or power of the Parliament of Canada to enact any laws whatsoever with respect to any area of law 

 

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for which the Parliament of Canada has legislative jurisdiction, even if the enactment of any such law affects the License Agreement, its interpretation, or the rights, obligations, liabilities, vested or not, accrued or accruing, of the Parties.

 

17.14      Compliance with Law

 

The Parties shall comply with all applicable laws, as those laws may be amended, revised, consolidated, substituted, from time to time, even if such amendment, revision, consolidation, substitution derogates prospectively or retroactivity from the Parties’ vested or accrued rights, obligations and liabilities under the License Agreement.

 

17.15      No Implied Obligations

 

No implied terms or obligations of any kind, by or on behalf of either of the Parties, shall arise from anything in the License Agreement.  The express covenants and agreements herein contained and made by the Parties are the only covenants and agreements upon which any rights against either of the Parties may be founded.

 

17.16      Access to Information

 

Notwithstanding any provision to the contrary in the License Agreement, the Company acknowledges that Canada is subject to the Access to Information Act, R.S.C. 1985, c.A-1 and related acts, and may be required to release, in whole or in part, the License Agreement and any other information or documents in Canada’s possession or control relating to the License Agreement and the Parties.

 

17.17      Forum Conveniens & Applicable Laws

 

Subject to Article 16 (ADR) any Dispute, shall be governed firstly by applicable Canadian Federal laws, and secondly by the laws of the Province of Ontario.

The Parties expressly exclude from the License Agreement:

 

17.17.1        application of the United Nations Convention on Contracts for the International Sale of Goods;

17.17.2        International Sales of Goods Act; and

17.17.3        any conflict of laws, venue, forum non-conveniens, rules or principles which might refer Disputes to the laws of another jurisdiction.

 

17.18      Attornment

 

The License Agreement shall be governed by and construed in accordance with the laws in force in the Province of Ontario, Canada and shall be treated in all respect as an Ontario, Canada contract.  Subject to Article 16 (Alternate Dispute Resolution (ADR)) the Parties irrevocably and unconditionally attorn to and submit to the exclusive jurisdiction of the courts of Ontario, Canada and all courts competent to hear appeals therefrom with respect to any Dispute now or hereinafter arising under the License Agreement.  The Parties waive any right each may have to object to an action being 

 

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brought in those courts including, without limitation, by claiming that the action has been brought in an inconvenient forum or that those courts do not have jurisdiction.

 

17.19      USA Jury Trial

 

If the License Agreement or any aspect of it becomes a subject of judicial proceedings whether in contract, tort, equity or otherwise, in the United States of America despite the ADR article and Forum Conveniens (paragraph 17.17), then the Company irrevocably waives any and all rights it has to a trial by jury in the United States.  The Company agrees and consents that due to the technical and legal nature, including cross jurisdictional issues of the License Agreement or any aspect thereof, any such proceedings will be heard before a judge sitting alone.

 

17.20      USA Jury Trial / Treble Damages Addendum

 

For greater clarity, the Company waives any right to a trial by jury of any claim, demand action or caution of action

 

17.20.1            arising under the License Agreement; or

17.20.2            in any way connect with or related or incidental to the dealings of the Parties in respect of the License Agreement or any other agreements or the transactions related hereto or thereto in each case whether now existing or hereafter;

17.20.3            whether in contract, tort, equity or otherwise.

 

The Company agrees and consents that any such claim, demand, action or cause of action shall be decided by a court without a jury.  Canada may file an original counterpart of the License Agreement with the court as written evidence of the consent of the Parties to the waiver of their right to a trial by jury.  In addition, the Company irrevocably waives any rights to triple/treble damages or punitive damages under U.S. or any other law.

 

17.21      Waiver of Counterclaims

 

The Company waives any and all of its rights to interpose any claims, deductions, setoffs or counterclaims of any nature in any Dispute with respect to the License Agreement.

 

17.22      Due Diligence Audits

 

If in a subsequent transaction a third Party requires to review this License Agreement as part of a due diligence chain of title search, the Company hereby authorizes the release of this License Agreement subject to deleting any financial or proprietary or other Confidential Information contained herein.

 

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17.23      Recitals Accurate

 

The Parties acknowledge the truth and accuracy of the recitals and further acknowledge that the recitals may be used by a court, mediator or arbitrator to help resolve any Dispute.

 

17.24      Force Majeure

 

17.24.1            EVENTS

 

Subject to making all payments required under the License Agreement, neither Party shall be in breach of any of its obligations under the License Agreement where the failure to perform or delay in performing any obligation is due, wholly or in part, directly or indirectly to the occurrence of a force majeure event including, without limitation:

 

17.24.1.2         war, whether declared or not, civil war, revolution, acts of piracy / terrorism, acts of sabotage;

17.24.1.3         natural disasters such as violent or destructive storms, cyclones, earthquakes, tidal waves floods, destruction by lightning;

17.24.1.4         explosions, fires, destruction of machines, factories, and any kind of installation;

17.24.1.5         boycotts, strikes and lock-outs of all kinds, go-slows, occupation of factories and premises, and work stoppages which occur in the enterprise of the Party seeking relief;

17.24.1.6         acts of governmental bodies, agencies, boards, whether lawful or unlawful other than those of the Public Health Agency of Canada,

 

but does not include:

 

17.24.1.7         the lack of regulatory or other approvals, licenses, permits and authorizations necessary for the performance of the License Agreement which are issued by a public authority of any kind whatsoever for which the Company did not apply for or diligently prosecute;

17.24.1.8         the inability of the affected Party to obtain financing or any other financial inability on the part of either Party to meet its obligations under the License Agreement;

17.24.1.9         force majeure events that the affected Party knew or should have reasonably known at the time of negotiating the License Agreement were probable or avoidable or the effects of which could be minimized, and the affected Party took no steps to deal with such force majeure events, including without limitation obtaining the appropriate insurance, using updated machinery;

17.24.1.10       the portion of the breach or delay due to the failure of the affected Party to take all necessary reasonable steps to minimize, overcome or control the effects of the force majeure event.

 

49

 

17.24.2            DUTY TO NOTIFY

 

The Party affected by a force majeure event as contemplated in subparagraph 17.24.1 (Force Majeure) shall:

 

17.24.2.2         give notice to the other Party of such force majeure and its effects on the affected Party’s ability to perform as soon as practicable after the force majeure and its effects upon the affected Party’s ability to perform become known to that Party.  Notice shall be given when the ground of relief ceases;

 

17.24.2.3         take all reasonable efforts to correct, compensate or minimize the effect of the force majeure event.

 

17.24.3            COMMENCEMENT OF RELIEF

 

The affected Party shall in the affected jurisdiction only:

 

17.24.3.2         be excused of its obligations under the License Agreement to the extent necessitated by the force majeure event from the time of the force majeure event or if notice was not given as soon as practical, from the receipt of such notice.  Failure to give notice makes the failing Party liable in damages for losses suffered by the other Party which otherwise could have been avoided; and

 

17.24.3.3         complete or continue performance of its obligations and duties under the License Agreement as soon as practical after the cessation, removal, or overcoming of the force majeure event.

 

17.24.4            TERMINATION OF AGREEMENT

 

If the force majeure event continues in excess of sixty (60) consecutive days, or in the aggregate 60 days over any consecutive 200 days, then at any time thereafter Canada shall have the option to renegotiate the License Agreement with the Company reasonably and in good faith.  If the Parties are unable to agree to the terms of the proposed amended License Agreement within 60 days from the notice to negotiate, then the License Agreement may be terminated by Canada on the 61st day.

 

17.24.5            POSTPONEMENT OF OBLIGATIONS

 

Any obligations of a Party under the License Agreement shall be postponed automatically to the extent and for the period and only within the jurisdiction or jurisdictions that the affected Party is prevented from meeting those obligations by reason of any cause beyond its reasonable control (other than lack of funds and applicable regulatory approval).  The affected Party shall immediately notify the other Party of the commencement, nature of such cause and probable consequence.  The affected Party shall also use its

 

50

 

reasonable best efforts to render performance in a timely manner, utilizing all resources reasonably required in the circumstances.

 

17.25      Waiver

 

No condoning, excusing, or overlooking by either of the Parties of any default by the other Party, at any time or times, in performing or observing any of the Parties’ respective covenants, will operate as a waiver renunciation, surrender, of or otherwise affect the rights of the Parties in respect of any continuing or subsequent default.  No waiver of these rights will be inferred from anything done or omitted by the Parties, except by an express waiver in writing.

 

17.26      No Estoppel Due to Third Party Practices

 

No custom, practice or usage regarding other License Agreements between Canada and other Parties shall preclude at any time the strict enforcement of the License Agreement by Canada or the Company.

 

17.27      Contract Always Speaks

 

Where a matter or thing is expressed in the present tense, it shall be applied to the circumstances as they arise, so that effect may be given to the License Agreement according to its true spirit, intent and meaning.

 

17.28      Time is of the Essence

 

Time is of the essence in the License Agreement with respect to the financial and Commercialization obligations of the Company.

 

17.29      Headings

 

17.29.1            All headings in the License Agreement have been inserted as a matter of convenience and for reference only, and in no way define, limit, enlarge, modify, the scope or meaning of the License Agreement or any of its provisions.

 

17.29.2            Nevertheless an arbitrator or Judge may use any or all of the table of contents, recitals, and headings when reviewing the covenants, statements, representations & warranties and conditions subsequent to better understand the commercial and legal intent of the License Agreement’s provisions.

 

17.30      Internal References

 

Any reference in the License Agreement to an Article, paragraph, sub-paragraph, will mean an Article, paragraph or sub-paragraph of the License Agreement, unless otherwise expressly provided.

 

51

 

17.31      Precedence Over Appendices

 

If there is a conflict or ambiguity between the License Agreement proper and any appendix thereto, the interpretation consistent with License Agreement proper (taking into consideration the statements in the recitals and headings) shall prevail and apply, notwithstanding any wording to the contrary in the applicable appendix.

 

17.32      Appendices

 

Subject to paragraph 17.31 (Precedent Over Appendices) the documents attached hereto as Appendix A, B, C and D form an integral part of this License Agreement as fully as if they were set forth herein in extenso, and consist of:

 

Appendix “A” — DESCRIPTION OF THE LICENSED RIGHTS
 Appendix “B” — CONFIDENTIALITY AGREEMENTS
 Appendix “C” — BUSINESS PLAN
 Appendix “D” — AFFILIATES

 

18.0        LEGAL RIGHTS

 

18.1        Amendments

 

No modification or waiver of any provision of the License Agreement will be inferred from anything done or omitted by either of the Parties, except by an express amendment in writing, duly executed by the Parties in advance.

 

18.2        No Assignment Without Consent

 

The License Agreement is personal to the Company.  The Company shall not assign the License Agreement or any of the Company’s rights, duties or obligations under the License Agreement to a third party without the prior written consent of Canada, such consent not to be unreasonably withheld.  Any attempt to assign this License Agreement or any of the Company’s rights, duties or obligations under the License Agreement without the prior written consent of Canada is void.

 

18.3        Mode of Assignment / Approval Conditions

 

Without derogating from paragraph 18.2 (Assignment), the Company shall not assign (or transfer, sell, encumber, pledge, grant a security interest sub-license or otherwise deal) or permit any such assignment, in whole or in part, of the License Agreement or any of its interest, rights or obligations hereunder, whether such assignment takes place by way of:

 

18.3.1              sale of assets;

 

18.3.2              sale of shares;

 

18.3.3              amalgamation, merger or other reorganization of the Company;

 

52

 

18.3.4              merger, transfer, conversion, assignment, redemption, issuance, sale, cancellation, pledge, conversion or other dealings with any securities of the Company;

 

18.3.5              operation of law;

 

18.3.6              acquisition by a person or persons acting in concert of a majority interest of the securities of the Company by a person or persons acting in concert who did not hold such a majority interest at the time of the initial public offering (IPO) or at any time after the IPO.

 

18.3.7              operation of contract; or

 

18.3.8              otherwise in any manner or structure whatsoever;

 

without the prior written consent of Canada, which consent subject to subparagraph 18.3.9 will not be unreasonably withheld.

 

18.3.9              Any consent from Canada shall be contingent and effective only upon receipt by Canada of payment of [*].

 

18.3.10            Consent to any assignment will not be construed as consent to any other assignment.

 

18.4        No Consent — Material Breach

 

Failure of the Company to obtain the prior written consent of Canada to any assignment shall be deemed to be a material breach of the License Agreement.

 

18.5        Assignment Prejudicial - Compensation

 

It will not be unreasonable for Canada to refuse to consent to any assignment if it is foreseeable that the assignment might negatively affect Canada in any way, or put Canada in breach of any contract with a third party or derogate from the Commercialization.  Notwithstanding the foregoing, Canada may still consent in exchange for payment of both  [*].

 

18.6        No Comfort Letter

 

Notwithstanding anything to the contrary in the License Agreement, Canada shall be under no obligation whatsoever to sign any a comfort letter or other undertaking to a third party for the benefit of the Company.  If Canada so elects pursuant to its unfettered discretion, then the Company shall pay or provide security in the amount of liability so accepted or incurred by Canada.

 

53

 

18.7        Subcontracting

 

The Company has the right to subcontract any portion, but not all, of the License Agreement, subject to the following:

 

18.7.1              subcontracting activities (including subcontracts entered into with contract research organizations) shall be carried out by the Company in a manner that is consistent with the Company’s obligations under paragraphs 2.4 to 2.7 of the License Agreement;

 

18.7.2              the Company shall notify Canada in writing of any significant subcontracts or subcontractors of whom the Company is aware may have an interest in the technology or a collaboration with Canada;

 

18.7.3              the subcontract cannot be a de facto assignment; and

 

18.7.4              no rights, obligations, power or control vested in the Company shall be contingently or otherwise transferred to any third party.

 

18.8        No Third Party Rights

 

Nothing expressed or implied in the License Agreement is intended to, or shall be construed to confer on or give to, any person other than the Parties, any rights or remedies under or by reason of the License Agreement.

 

18.9        Remedies Cumulative

 

All rights, powers and remedies provided by the License Agreement are cumulative with, and not exclusive of, the rights, powers or remedies provided by law or equity independently of the License Agreement.

 

18.10      Mutual Assistance

 

The Parties will at all times hereafter, upon every reasonable request of the other, make, do, and execute or cause to be procured, made, done, and executed, all such further acts, deeds and assurances for the carrying out of the terms, covenants and agreements of the License Agreement, according to the true intent and meaning of the License Agreement.  These obligations shall continue post termination or expiry until all pre and post termination obligations are satisfied.

 

18.11      Counterpart

 

The License Agreement may be executed simultaneously in counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

54

 

19.0        CROWN GENERAL

 

19.1        No Bribes

 

The Company warrants that no bribe, gift, or other inducement has been paid, given, promised or offered to any Government official or employee for the obtaining of this License Agreement.

 

19.2        No Share to Members of Parliament

 

Pursuant to the Parliament of Canada Act, R.S.C. 1985, c.P-1, no member of the House of Commons or Senate will be admitted to any share or part of the License Agreement or to any benefit arises from the License Agreement.

 

19.3        Public Office Holders

 

It is a term of this License Agreement that no former public Office holder, who is not in compliance with the post employment provisions of the Conflict of Interest and Post Employment Code for Public Office Holders, shall derive a direct benefit from this License Agreement.

 

20.0        NOTICE

 

20.1        Addresses / Contacts

 

Wherever in this License Agreement it is required or permitted that notice or demand be given, or served by either Party to or on the other Party, such notice or demand will be in writing and will be validly given or sufficiently communicated if hand delivered or forwarded by certified mail, priority post mail, telegram, or facsimile or sent by overnight delivery by a nationally recognized courier as follows:

 

The addresses for delivery are:

 

To the Company:

 

Nicholas Vahanian
 Chief Medical Officer
 BioProtection Systems Corporation
 2901 S. Loop Dr., Suite 3360
 Ames, IA, USA
 50010
 Telephone:  (515) 598-2922
 Facsimile:  (515) 296-3820
 Email:  nvahanian@linkp.com

 

55

 

To Canada:

 

Dorothea Blandford, PhD
 Director, Intellectual Property Management & Business Development Operations
 Public Health Agency of Canada
 1015 Arlington Street, Suite 2420
 Winnipeg, Manitoba
 Canada R3E 3R2
 Telephone:  (204) 789-2096
 Facsimile:  (204) 789-2097
 Email:  dorothea_blanciford@hc-sc.dc.ca

 

The Parties shall send an e-mail version of the notice or demand at least 24 hours prior to the hard or facsimile copy, but failure to send the email version does not invalidate or otherwise make subsequent service of the notice defective,

 

20.2        Deemed Delivery

 

Notice will be deemed to have been delivered:

 

20.2.1              if delivered by hand, upon receipt;

 

20.2.2              if sent by electronic transmission, forty-eight (48) hours after the time of confirmed transmission, excluding from the calculation weekends and public holidays;

 

20.2.3              if sent by certified mail, four (4) days after the mailing thereof, provided that if there is a postal strike or other disruption, such notice will be delivered by hand or electronic transmission.

 

20.3        Change of Address

 

The Parties may change their respective addresses for delivery by delivering notice of change as provided in this paragraph.

 

21.0        EXECUTION

 

IN WITNESS WHEREOF this License Agreement has been executed in duplicate by the duly authorized representatives of the Parties, on the date(s) set out below.

 

56

 

FOR HER MAJESTY THE QUEEN IN RIGHT OF CANADA:

 

 

	
 
    	
 
    	
 
    	
 
    	
 
    
	
Frank   A. Plummer, O.C. O.M.
    	
 
    	
(Date)
    	
 
    	
(Witness)
    
	
MD   LL.D, FRCPC, FRSC
    	
 
    	
 
    	
 
    	
 
    
	
Chief   Science Advisor
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
FOR   THE COMPANY:
    	
 
    	
 
    	
 
    	
 
    

 

 

	
 
    	
 
    	
 
    	
 
    	
 
    
	
Nicholas   Vahanian, MD
    	
 
    	
(Date)
    	
 
    	
(Witness)
    
	
Chief   Medical Officer
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
I   have authority to bind the corporation
    	
 
    	
 
    	
 
    	
 
    

 

57

 

APPENDIX “A” DESCRIPTION OF THE LICENSED RIGHTS

 

[*]Recombinant Vesicular Stomatitis Virus Vaccines for Viral Hemorrhagic Fevers [*].

 

[*]Recombinant Vesicular Stomatitis Virus Vaccines for Viral Hemorrhagic Fevers [*].

 

[*]Recombinant Vesicular Stomatitis Virus Vaccines for Viral Hemorrhagic Fevers [*].

 

58

 

APPENDIX “B” CONFIDENTIALITY AGREEMENTS

 

(APPENDED OVER THE NEXT 8 PAGES)

 

59

 

 

Office of Director

Business Development and Operations

National Microbiology Laboratory

1015 Arlington Street

Winnipeg, Manitoba R3E 3R2

 

April 14, 2010

 

Nicholas Vahanian

BioProtection Systems Corporation

Iowa Stale University Research Park,

2901 South Loop Drive, Suite 3360,

Ames, Iowa 50010

 

RE:  Non Disclosure Agreement dated, November 18, 2008 between the Public Health Agency of Canada (referred to as “PHAC”), and BioProtection Systems Corporation (referred to as “BPS”).

 

Dear Dr Vahanian,

 

PHAC and BPS have executed a Non Disclosure Agreement dated November 18, 2008.  The parties hereby agree to amend the Agreement as follows:

 

i)              Section 9C, “The term of this Agreement shall commence on its effective date and remain in force for eighteen (18) months thereafter, except that the Agreement shall remain effective with respect to the confidential information disclosed under this Agreement for the remainder of any period of confidentiality pursuant to subparagraph 9b above.”

 

Shall be replaced by

 

Section 9C “The term of this Agreement shall commence on its effective date and remain in force for sixty (60) months thereafter, except that the Agreement shall remain effective with respect to the confidential information disclosed under this Agreement for the remainder of any period of confidentiality pursuant to subparagraph 9b above.”

 

All other terms and conditions of the Agreement will remain in full force and effect and shall continue the duration of the Agreement.  This letter, upon execution by both parties, shall form part of the Agreement and the two documents shall be read together.

 

60

 

 

If the foregoing amendment is satisfactory, please counter sign this letter on behalf of the Participants in the spaces provided, and return the signed letter to our office via electronic PDF copy to sabrina_choma@phac-aspc.gc.ca

 

Sincerely,

 

 

	
 
    	
 
    
	
Frank   A. Plummer OC, MD, LL.D, FRCP(C), FRSC
    	
 
    
	
Scientific   Director General
    	
 
    
	
National   Microbiology Laboratory
    	
 
    
	
 
    	
 
    
	
Acknowledged   and agreed to on behalf of BPS:
    	
 
    

 

 

	
 
    	
 
    	
 
    
	
Name:
    	
Carl   Langren
    	
 
    
	
Title:
    	
Chief   Financial Officer
    	
 
    

 

61

 

 

THE PARTIES ARE:                           Her Majesty the Queen in Right of Canada as represented by the Minister of Health (“Public Health Agency of Canada”)

 

Whose address is:

National Microbiology Laboratory

Canadian Science Centre for Human and Animal Health Canada

1015 Arlington Street, Winnipeg, MB R3E 3R2, CANADA

(called “PHAC”) OF THE FIRST PART

 

AND:                                                                                                                                                               BioProtection Systems Corporation

 

Whose address is

Iowa State University Research Park, 2901 South Loop Drive,

Suite 3360, Ames Iowa 50010

(called the “Participant”) OF THE SECOND PART

 

Effective Date:  November 1, 2008

 

In order to protect certain confidential information the Parties identified above, agree on terms about confidentiality which fairly protects both parties.

 

1.             Disclosing Party:  The party(ies) disclosing confidential information (“Disclosing Party”) is/are:  Public Health Agency at Canada, National Microbiology Laboratory, 1015 Arlington Street, Winnipeg. MB 133E 3R2, and BioProtection Systems Corporation, 2901 South Loop Drive, Suite 3360, Ames, Iowa 50010.

 

2.             Primary Representative:  The representative(s) of each party for coordinating the disclosure and/or receipt of confidential information are:  Dr. Steven Jones and Dr. Dorothea Blandford and Dr. Nicholas Vahanian.

 

3.             Description of Confidential Information:  The subject matter of the confidential information disclosed under this Agreement is described as:

Public Health Agency of Canada:  [*].

Participant:  scientific and technical information relating to the pipeline products; business information.

 

4.             Use of Confidential Information:  The party receiving the confidential information (“Recipient”) shall keep the confidential information in strict confidence and shall make use of the confidential information only for the following purpose:  to discuss scientific and business arrangements in view of negotiating a license agreement.

 

5a.           Standard of Care:  Recipient shall protect the disclosed confidential information by using the same degree of care, but no less than a reasonable degree of care, to prevent the unauthorized

 

62

 

use, dissemination, or publication of the confidential information, as Recipient uses to protect its own confidential information of a like nature.

 

5b.           In particular, and without limiting the generality of the foregoing, Recipient shall not copy, reproduce, divulge, publish or circulate (or permit anyone else to do so) any of the confidential information disclosed to it by the Disclosing Party, except to such of its employees [and/or contractors and consultants] as may require access to the confidential information on a strict need-to-know basis for the uses contemplated in paragraph 4.

 

6.             Markings:  Recipient’s obligations shall extend to confidential information that is described in paragraph 3, and that (a) if set out in written, graphical, photographic or other tangible form (including, without limitation thereto, machine readable object code), is marked “Confidential’ or “Proprietary” by the Disclosing Party, or (b) if disclosed orally, is identified as confidential or proprietary at the time of disclosure and a written summary thereof marked ‘Confidential” or ‘Proprietary” is furnished by the Disclosing Party to Recipient within thirty (30) days after such oral disclosure.

 

7.             Exclusions:  This Agreement imposes no obligation upon Recipient with respect to information that:  (a) was in Recipient’s possession before receipt from the Disclosing Party; (b) is or becomes a matter of public knowledge through no fault of Recipient; (c) is rightfully received by Recipient from a third party without a duty of confidentiality; (d) is disclosed by the Disclosing Party to a third party without a duty of confidentiality on the third party; (e) is independently developed by Recipient; (f) is disclosed under operation of law, including the Access to Information Act of Canada; or (g) is disclosed by Recipient with the Disclosing Party’s prior written approval.

 

8.             Warranty:  Each Disclosing Party warrants that it has the right to make the disclosures under this Agreement.

 

NO OTHER WARRANTIES ARE MADE BY EITHER PARTY UNDER THIS AGREEMENT.  ANY INFORMATION EXCHANGED UNDER THIS AGREEMENT IS PROVIDED “AS IS”.

 

NEITHER PARTY PROVIDES ANY OTHER REPRESENTATION, WARRANTY, ASSURANCE OR GUARANTEE OF ANY KIND WITH RESPECT TO THE CONFIDENTIAL INFORMATION IT DISCLOSES.

 

9a.           Rights:  Neither party acquires any intellectual property rights under this Agreement except the limited rights necessary to carry out the purposes set forth in paragraph 4.  This Agreement shall not restrict reassignment of Recipient’s employees.

 

9b.           The obligations set out in paragraphs 4 and 5 above shall become effective with respect to any confidential information immediately upon its disclosure by the Disclosing Party to Recipient and shall continue for a period of three (3) years thereafter.

 

9c.           The term of this Agreement shall commence on its effective date and remain in force for 18 months thereafter, except that the Agreement shall remain effective with respect to the

 

63

 

confidential information disclosed under this Agreement for the remainder of any period of confidentiality pursuant to subparagraph 9b above.

 

9d.           Upon request made by the Disclosing Party during the term of the Agreement, Recipient shall return the confidential information and all copies thereof to the Disclosing Party or, at the option of the Disclosing Party, destroy the confidential information and all copies thereof, and Recipient shall certify in writing within five (5) days of the receipt of the request from the Disclosing Party that it has complied with that request.

 

Miscellaneous

 

10.           The only terms concerning confidentiality relating to the information described in paragraph 3 are in this Agreement and in the Access to Information Act of Canada.

 

11.           This Agreement imposes no obligation on either party to purchase, sell, licence, transfer or otherwise dispose of any technology, services or products, and neither this Agreement nor the disclosure or receipt of confidential information under this Agreement constitutes or implies any undertaking or commitment by either party to enter into any further activity, arrangement or course of action with the other party or with any third party.

 

12.           Both parties shall adhere to all applicable laws, regulations and rules relating to the export of technical data, and shall not export or re-export any technical data, any products received from the Disclosing Party, or the direct product of such technical data to any prescribed country listed in such applicable laws, regulations and rules unless properly authorized.

 

13.           This Agreement does not create any agency or partnership relationship.

 

14.           This Agreement cannot be modified except by a document signed by both Parties that explicitly refers to this Agreement.

 

 

64

 

 

THE PARTIES ARE:                         Her Majesty the Queen in Right of Canada as represented by the Minister of Health (“Public Health Agency of Canada”)

 

Whose address is

National Microbiology Laboratory

Canadian Science Centre for Human and Animal Health Canada

1015 Arlington Street, Winnipeg, MB R3E 3R2, CANADA

(called “PHAC”) OF THE FIRST PART

 

AND:                                                                                                                                                               BioProtection Systems Corporation

 

Whose address is

Iowa State University Research Park, 2901 South Loop Drive,

Suite 3360, Ames Iowa 50010

(called the “Participant’) OF THE SECOND PART

 

Effective Date:  May 1, 2007

 

In order to protect certain confidential information the Parties identified above, agree on terms about confidentiality which fairly protects both parties.

 

1.             Disclosing Party:  The party(ies) disclosing confidential information (“Disclosing Party”) is/are:  Public Health Agency of Canada, National Microbiology Laboratory, 1015 Arlington Street, Winnipeg, MB R3E 3R2, and BioProtection Systems Corporation, 2901 South Loop Drive, Suite 3360, Ames, Iowa 50010.

 

2.             Primary Representative.  The representative(s) of each party for coordinating the disclosure and/or receipt of confidential information are:  Dr. Heinz Feldmann and Dr. Dorothea Blandford and Dr. Nicholas Vahanian.

 

3.             Description of Confidential Information:  The subject matter of the confidential information disclosed under this Agreement is described as:

Public Health Agency of Canada:  [*]

Participant:  scientific and technical information relating to the pipeline products:  business information.

 

4.             Use of Confidential Information:  The party receiving the confidential information (“Recipient”) shall keep the confidential information in strict confidence and shall make use of the confidential information only for the following purpose:  to discuss scientific and business arrangements in view of negotiating a license agreement.

 

65

 

5a.           Standard of Care:  Recipient shall protect the disclosed confidential information by using the same degree of care, but no less than a reasonable degree of care, to prevent the unauthorized use, dissemination, or publication of the confidential information, as Recipient uses to protect its own confidential information of a like nature.

 

5b.           In particular, and without limiting the generality of the foregoing, Recipient shall not copy, reproduce, divulge, publish or circulate (or permit anyone else to do so) any of the confidential information disclosed to it by the Disclosing Party, except to such of its employees [and/or contractors and consultants] as may require access to the confidential information on a strict need-to-know basis for the uses contemplated in paragraph 4.

 

6              Markings:  Recipient’s obligations shall extend to confidential information that is described in paragraph 3, and that (a) if set out in written, graphical, photographic or other tangible form (including, without limitation thereto, machine readable object code), is marked “Confidential” or “Proprietary” by the Disclosing Party, or (b) if disclosed orally, is identified as confidential or proprietary at the time of disclosure and a written summary thereof marked “Confidential” or “Proprietary” is furnished by the Disclosing Party to Recipient within thirty (30) days after such oral disclosure.

 

7.             Exclusions:  This Agreement imposes no obligation upon Recipient with respect to information that:  (a) was in Recipient’s possession before receipt from the Disclosing Party; (b) is or becomes a matter of public knowledge through no fault of Recipient; (c) is rightfully received by Recipient from a third party without a duty of confidentiality:  (d) is disclosed by the Disclosing Party to a third party without a duty of confidentiality on the third party; (e) is independently developed by Recipient; (1) is disclosed under operation of law, including the Access to information Act of Canada; or (g) is disclosed by Recipient with the Disclosing Party’s prior written approval.

 

8.             Warranty:  Each Disclosing Party warrants that it has the right to make the disclosures under this Agreement.

 

NO OTHER WARRANTIES ARE MADE BY EITHER PARTY UNDER THIS AGREEMENT, ANY INFORMATION EXCHANGED UNDER THIS AGREEMENT IS PROVIDED “AS IS”.

 

NEITHER PARTY PROVIDES ANY OTHER REPRESENTATION, WARRANTY, ASSURANCE OR GUARANTEE OF ANY KIND WITH RESPECT TO THE CONFIDENTIAL INFORMATION IT DISCLOSES.

 

9a.           Rights:  Neither party acquires any intellectual property rights under this Agreement except the limited rights necessary to carry out the purposes set forth in paragraph 4.  This Agreement shall not restrict reassignment of Recipient’s employees.

 

9b.           The obligations set out in paragraphs 4 and 5 above shall become effective with respect to any confidential information immediately upon its disclosure by the Disclosing Party to Recipient and shall continue for a period of three (3) years thereafter.

 

66

 

9c.           The term of this Agreement shall commence on its effective date and remain in force for 18 months thereafter, except that the Agreement shall remain effective with respect to the confidential information disclosed under this Agreement for the remainder of any period of confidentiality pursuant to subparagraph 9b above.

 

9d.           Upon request made by the Disclosing Party during the term of the Agreement, Recipient shall return the confidential information and all copies thereof to the Disclosing Party or, at the option of the Disclosing Party, destroy the confidential information and all copies thereof, and Recipient shall certify in writing within five (5) days of the receipt of the request from the Disclosing Party that it has complied with that request.

 

Miscellaneous

 

10.           The only terms concerning confidentiality relating to the information described in paragraph 3 are in this Agreement and in the Access to Information Act of Canada.

 

11.           This Agreement imposes no obligation on either party to purchase, sell, licence, transfer or otherwise dispose of any technology, services or products, and neither this Agreement nor the disclosure or receipt of confidential information under this Agreement constitutes or implies any undertaking or commitment by either party to enter into any further activity, arrangement or course of action with the other party or with any third party.

 

12.           Both parties shall adhere to all applicable laws, regulations and rules relating to the export of technical data, and shall not export or re-export any technical data, any products received from the Disclosing Party, or the direct product of such technical data to any prescribed country listed in such applicable laws, regulations and rules unless properly authorized.

 

13.           This Agreement does not create any agency or partnership relationship

 

14.           This Agreement cannot be modified except by a document signed by both Parties that explicitly refers to this Agreement.

 

 

67

 

APPENDIX “C” BUSINESS PLAN

 

(TO FOLLOW WITHIN 30 DAYS OF EXECUTION)

 

68

 

APPENDIX “D” AFFILIATES

 

NewLink Genetics Corporation, 2901 South Loop Drive, Suite 3900, Ames, Iowa, USA 50010

 

69Exhibit 10.70

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

 

1

 

Section B - Supplies or Services and Prices

 

BAA REFERENCE

This contract is awarded as a result of Solicitation HDTRA1-07-RDINO-BAA, Broad Agency Announcement.

 

	
ITEM NO
    	
 
    	
SUPPLIES/SERVICES
    	
 
    	
QUANTITY
    	
 
    	
UNIT
    	
 
    	
UNIT PRICE
    	
 
    	
AMOUNT
    	
 
    
	
0001
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Lot
    	
 
    	
 
    	
 
    	
$
    	
3,707,837.00
    	
 
    
	
 
    	
 
    	
Base   Period
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CPFF
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
In   accordance with Statement of Work entitled “aGal Adjuvant Technology for   Biodefense Agents,” dated March 15, 2009 as attachment number one.
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
FOB:   Destination
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
PURCHASE   REQUEST NUMBER: CBS080011915
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
ESTIMATED COST
    	
 
    	
$
    	
3,408,767.00
    	
 
    
	
 
    	
 
    	
FIXED FEE
    	
 
    	
$
    	
299,070.00
    	
 
    
	
 
    	
 
    	
TOTAL EST COST + FEE
    	
 
    	
$
    	
3,707,837.00
    	
 
    

 

	
ITEM NO
    	
 
    	
SUPPLIES/SERVICES
    	
 
    	
QUANTITY
    	
 
    	
UNIT
    	
 
    	
UNIT PRICE
    	
 
    	
AMOUNT
    	
 
    
	
000101
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
Base   Period Funding
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CPFF
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
FOB:   Destination
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
PURCHASE   REQUEST NUMBER: CBS080011915
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
ESTIMATED COST
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
FIXED FEE
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
TOTAL EST COST + FEE
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
ACRN   AA
    	
 
    	
$
    	
1,429,820.00
    	
 
    
	
 
    	
 
    	
CIN:   CBS080011915000101
    	
 
    	
 
    	
 
    

 

2

 

	
ITEM NO
    	
 
    	
SUPPLIES/SERVICES
    	
 
    	
QUANTITY
    	
 
    	
UNIT
    	
 
    	
UNIT PRICE
    	
 
    	
AMOUNT
    	
 
    
	
000102
    	
 
    	
 
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
Base   Period Funding
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CPFF
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
FOB:   Destination
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
PURCHASE   REQUEST NUMBER: CBM09001379
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
ESTIMATED COST
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
FIXED FEE
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
TOTAL EST COST + FEE
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
ACRN   AB
    	
 
    	
$
    	
2,278,017.00
    	
 
    
	
 
    	
 
    	
CIN:   CBM090013719000102
    	
 
    	
 
    	
 
    

 

	
ITEM NO
    	
 
    	
SUPPLIES/SERVICES
    	
 
    	
QUANTITY
    	
 
    	
UNIT
    	
 
    	
UNIT PRICE
    	
 
    	
AMOUNT
    	
 
    
	
0002
    	
 
    	
 
    	
 
    	
NSP
    	
 
    
	
 
    	
 
    	
Contract   Data Requirements List
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CPFF
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CDRLS   IAW attachment 1
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
FOB:   Destination
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
PURCHASE   REQUEST NUMBER: CBS080011915
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
ESTIMATED COST
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
FIXED FEE
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
TOTAL EST COST + FEE
    	
 
    	
$
    	
0.00
    	
 
    

 

See Exhibit A

 

	
ITEM NO
    	
 
    	
SUPPLIES/SERVICES
    	
 
    	
QUANTITY
    	
 
    	
UNIT
    	
 
    	
UNIT PRICE
    	
 
    	
AMOUNT
    	
 
    
	
0003
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Lot
    	
 
    	
 
    	
 
    	
$
    	
6,891,784.00
    	
 
    
	
OPTION
    	
 
    	
Option   Year One
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
CPFF
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
FOB:   Destination
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
ESTIMATED COST
    	
 
    	
$
    	
6,705,742.00
    	
 
    
	
 
    	
 
    	
FIXED FEE
    	
 
    	
$
    	
186,042.00
    	
 
    
	
 
    	
 
    	
TOTAL EST COST + FEE
    	
 
    	
$
    	
6,891,784.00
    	
 
    
														

 

3

 

Section C - Descriptions and Specifications

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.211-9000 Description/Specifications/Work Statement

 

The Contractor shall provide the supplies and/or services set forth in Section B, in accordance with the following:

 

a.  Statement of Work entitled “aGal adjuvant Technology for Biodefense Agents”, Dated March 15, 2009, Attachment 1 to the Contract.

 

b.  Contract Data Requirements List (DD Form 1423), Exhibit A to the Contract.

 

4

 

Section D - Packaging and Marking

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.247-9001 PACKAGING AND MARKING

 

(a)  All data contained in Exhibit A, Contract Data Requirements List (CDRL), DD Form 1423 delivered under this contract shall be delivered using best commercial practices to meet the packaging requirements of the carrier and to insure delivery, to the addressees specified on the Data Item Cover Sheet, at destination and in accordance with applicable security requirements.

 

(b)  All data and correspondence submitted to the Contracting Officer shall reference the Contract Number, the CDRL number, and the date submitted. A copy of all correspondence sent to the Contracting Officer’s Representative (COR) or Project Manager shall be simultaneously provided to the Contracting Officer.

 

5

 

Section E - Inspection and Acceptance

 

INSPECTION AND ACCEPTANCE TERMS

 

Supplies/services will be inspected/accepted at:

 

	
CLIN
    	
 
    	
INSPECT AT
    	
 
    	
INSPECT BY
    	
 
    	
ACCEPT AT
    	
 
    	
ACCEPT BY
    
	
0001
    	
 
    	
Destination
    	
 
    	
Government
    	
 
    	
Destination
    	
 
    	
Government
    
	
000101
    	
 
    	
Destination
    	
 
    	
Government
    	
 
    	
Destination
    	
 
    	
Government
    
	
000102
    	
 
    	
Destination
    	
 
    	
Government
    	
 
    	
Destination
    	
 
    	
Government
    
	
0002
    	
 
    	
Destination
    	
 
    	
Government
    	
 
    	
Destination
    	
 
    	
Government
    
	
0003
    	
 
    	
Destination
    	
 
    	
Government
    	
 
    	
Destination
    	
 
    	
Government
    

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.246-9000 INSPECTION AND ACCEPTANCE (JUL 2007)

 

Government inspection and acceptance of data is specified on the Contract Data Requirements List, DD Form 1423. In accordance with FAR 52.246-9, inspection and acceptance for all work performed at any and all times under this contract shall be the responsibility of the:

 

x                                Contracting Officer’s Representative (COR) or Project Manager (PM). The Wide Area Work Flow (WAWF) Acceptor DoDDAC is located in DTRA 252.201-9000 Project Manager or DTRA 252.201-9002 Contracting Officer’s Representative.

 

o                             Administrative Contracting Officer (ACO). The WAWF Acceptor DoDAAC can be found in the “Administered By” block on page 1 of the contract.

 

(End of Clause)

 

6

 

Section F - Deliveries or Performance

 

DELIVERY INFORMATION

 

	
CLIN
    	
 
    	
DELIVERY DATE
    	
 
    	
QUANTITY
    	
 
    	
SHIP TO ADDRESS
    	
 
    	
UIC
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
0001
    	
 
    	
POP 25-SEP-2009 TO 24-SEP-2011
    	
 
    	
N/A
    	
 
    	
DEFENSE THREAT REDUCTION

AGENCY/RD-CBM

SEE SEPARATE LETTER

8725 JOHN J KINGMAN ROAD,

MAIL STOP 6201,

FORT BELVOIR VA 22060

FOB: Destination
    	
 
    	
HDTRA1
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
000101
    	
 
    	
N/A
    	
 
    	
N/A
    	
 
    	
N/A
    	
 
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
000102
    	
 
    	
N/A
    	
 
    	
N/A
    	
 
    	
N/A
    	
 
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
0002
    	
 
    	
POP 25-SEP-2009 TO 24-SEP-2012
    	
 
    	
N/A
    	
 
    	
DEFENSE THREAT REDUCTION

AGENCY/RD-CBM

SEE SEPARATE LETTER

8725 JOHN J KINGMAN ROAD,

MAIL STOP 6201,

FORT BELVOIR VA 22060

FOB: Destination
    	
 
    	
HDTRA1
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
0003
    	
 
    	
POP 25-SEP-2011 TO 24-SEP-2012
    	
 
    	
N/A
    	
 
    	
(SAME AS PREVIOUS LOCATION)

FOB: Destination
    	
 
    	
HDTRA1
    

 

CLAUSES INCORPORATED BY REFERENCE

 

	
52.242-15 Alt I
    	
Stop-Work Order (Aug 1989) - Alternate I
    	
APR 1984
    
	
52.247-34
    	
F.O.B. Destination
    	
NOV 1991
    

 

7

 

Section G - Contract Administration Data

 

ADMINISTRATION

 

ASSIGNMENT OF CONTRACT ADMINISTRATION SERVICES (CAS)

FUNCTIONS (AUG 2007)

 

a.  The contract administration functions stated in FAR 42.302(a) are assigned to:

See Section A, Block 6.

 

b.  Notwithstanding that assignment, in accordance with FAR 42.202(b)(2), the following functions are determined to be best performed by the PCO and are retained by the DTRA Contracting Office:

 

(1)  FAR 42.302(a)(3) Conduct postaward orientation conferences.

 

(2)  FAR 42.302(a)(20) Perform Postaward Security Administration.

 

(3)  FAR 42.302(a)(40) Perform engineering surveillance to assess compliance with contractual terms for schedule, cost, and technical performance in the areas of design, development, and production.

 

(4)  FAR 42.302(a)(51) In accordance with FAR 52.244-2, consent to the placement of subcontracts which have experimental, developmental, or research work as one of its purposes.

 

(5)  Approval or disapproval of the data items listed on Exhibit A, DD Form 1423, Contract Data Requirements List.

 

(END OF CLAUSE)

 

ACCOUNTING AND APPROPRIATION DATA

 

AA: 9780400.2620 1000 B62D 255999 BD27846000 S49012

AMOUNT: $1,429,820.00

CIN CBS080011915000101: $1,429,820.00

 

AB: 9790400.2620 1000 B62D 255999 BD29356000 S49012

AMOUNT: $2,278,017.00

CIN CBM090013719000102: $2,278,017.00

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.201-9002 CONTRACTING OFFICER’S REPRESENTATIVE (MAY 2007)

 

a.  The Contracting Officer’s Representative (COR) for this contract is:

 

8

 

x                                 SEE SEPARATE LETTER
  Defense Threat Reduction Agency/                        
 8725 John J. Kingman Rd, MS 6201
 Fort Belvoir VA 22060-6201
 Telephone number (703)
 e-mail address                       @dtra.mil.
 WAWF Acceptor DoDAAC: HDTRA1
  
 Defense Threat Reduction Agency/                     
 1680 Texas St SE
 Kirtland AFB NM 87117-5669
 Telephone number (505)           -         
 e-mail address                 @abq.dtra.mil.
 WAWF Acceptor DoDAAC: HDTRA2

 

b.  The COR will act as the Contracting Officer’s Representative for technical matters providing technical direction and discussion as necessary with respect to the specification/statement of work and monitoring the progress and quality of the Contractor’s performance. The COR is NOT an Administrative Contracting Officer (ACO) and does not have the authority to take any action, either directly or indirectly that would change the pricing, quality, quantity, place of performance, delivery schedule, or any other terms and conditions of the contract, or to direct the accomplishment of effort, which goes beyond the scope of the specifications/statement of work in the contract.

 

c.  When, in the opinion of the contractor, the COR requests effort outside the existing scope of the contract, the contractor shall promptly notify the Contracting Officer in writing. No action shall be taken by the contractor under such direction until the Contracting Officer has issued a modification to the contract or has otherwise resolved the issue.

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.204-9002 PAYMENT INSTRUCTIONS FOR MULTIPLE ACCOUNTING CLASSIFICATION CITATIONS (AUG 2007)

 

In accordance with DFARS 204.7108 Payment Instructions, payment shall be made by the numbered payment instruction identified below:

 

o                                  (1) Line item specific: single funding.  If there is only one source of funding for the contract line item (i.e., one ACRN), the payment office will make payment using the ACRN funding of the line item being billed.

 

o                                  (2) Line item specific: sequential ACRN order.  If there is more than one ACRN within a contract line item, the payment office will make payment in sequential ACRN order within the line item, exhausting all funds in the previous ACRN before paying from the next ACRN using the following sequential order: Alpha/Alpha; Alpha/Numeric; Numeric/Alpha; and Numeric/Numeric.

 

o                                  (3) Line item specific: contracting officer specified ACRN order.  If there is more than one ACRN within a contract line item, the payment office will make payment within the line item in the sequence

 

9

 

ACRN order specified by the contracting officer, exhausting all funds in the previous ACRN before paying from the next ACRN.

 

x                                  (4) Line item specific: by fiscal year. If there is more than one ACRN within a contract line item, the payment office will make payment using the oldest fiscal year appropriations first, exhausting all funds in the previous fiscal year before disbursing from the next fiscal year. In the event there is more than one ACRN associated with the same fiscal year, the payment amount shall be disbursed from each ACRN within a fiscal year in the same proportion as the amount of funding obligated for each ACRN within the fiscal year.

 

o                                    (5) Line item specific: by cancellation date. If there is more than one ACRN within a contract line item, the payment office will make payment using the ACRN with the earliest cancellation date first, exhausting all funds in that ACRN before disbursing funds from the next. In the event there is more than one ACRN associated with the same cancellation date, the payment amount shall be disbursed from each ACRN with the same cancellation date in the same proportion as the amount of funding obligated for each ACRN with the same cancellation date.

 

o                                    (6) Line item specific: proration. If there is more than one ACRN within a contract line item, the payment office will make payment from each ACRN in the same proportion as the amount of funding currently unliquidated for each ACRN.

 

o                                    (7) Contract-wide: sequential ACRN order.  The payment office will make payment in sequential ACRN order within the contract or order, exhausting all funds in the previous ACRN before paying from the next ACRN using the following sequential order: alpha/alpha; alpha/numeric; numeric/alpha; and numeric/numeric.

 

o                                    (8) Contract-wide: contracting officer specified ACRN order.  The payment office will make payment in sequential ACRN order within the contract or order, exhausting all funds in the previous ACRN before paying from the next ACRN in the sequence order specified by the contracting officer.

 

o                                    (9) Contract-wide: by fiscal year. The payment office will make payment using the oldest fiscal year appropriations first, exhausting all funds in the previous fiscal year before disbursing from the next fiscal year. In the event there is more than one ACRN associated with the same fiscal year, the payment amount shall be disbursed from each ACRN within a fiscal year in the same proportion as the amount of funding obligated for each ACRN within the fiscal year.

 

o                                    (10) Contract-wide: by cancellation date. The payment office will make payment using the ACRN with the earliest cancellation date first, exhausting all funds in that ACRN before disbursing funds from the next. In the event there is more than one ACRN associated with the same cancellation date, the payment amount shall be disbursed from each ACRN with the same cancellation date in the same proportion as the amount of funding obligated for each ACRN with the same cancellation date.

 

o                                    (11) Contract-wide: proration. The payment office will make payment from each ACRN within the contract or order in the same proportion as the amount of funding currently unliquidated for each ACRN.

 

o                                    (12) Other. If none of the standard payment instructions identified in paragraphs (d)(1) through (11) of this section are appropriate, the contracting officer may insert other payment instructions, provided the other payment instructions—

 

(i)                                Provide a significantly better reflection of how funds will be expended in support of contract performance; and

(ii)                             Are agreed to by the payment office and the contract administration office.

 

10

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.232-9007                             PAYMENT INFORMATION IN CENTRAL CONTRACTOR REGISTRATION (CCR) DATABASE

 

This contract contains FAR clause 52.204-7, Central Contractor Registration. All contractors must be registered in the CCR database prior to award, during performance, and through final payment of any contract, except for awards to foreign vendors for work to be performed outside the United States.

 

The Contractor is responsible for the accuracy and completeness of the data within the CCR, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. In addition to the contractor’s requirement to confirm on an annual basis that its information in the CCR database is accurate and complete, the contractor’s information in the CCR database must be updated whenever changes occur to the contractor’s remit-to data (e.g., account number, vendor name and address, etc.) and the paying office notified of any changes. The contractor’s failure to maintain accurate information in the CCR database could result in payment delays for which the Government shall not be liable.

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.232-9012 WIDE AREA WORK FLOW (WAWF) — RECEIPT AND ACCEPTANCE (RA) INSTRUCTIONS (December 2007)

 

(a)  As prescribed in DFARS clause 252.232-7003 Electronic. Submission of Payment Requests (Jan 2004), Contractors must submit payment requests in electronic form. Paper copies will no longer be accepted or processed for payment unless the conditions of DFARS clause 252.232-7003(c) apply. To facilitate this electronic submission, the Defense Threat Reduction Agency (DTRA) has implemented the DoD sanctioned Wide Area Workflow-Receipt and Acceptance (WAWF-RA) for contractors to submit electronic payment requests and receiving reports. The contractor shall submit electronic payment requests and receiving reports via WAWF-RA. Vendors shall send an email notification to the Contracting Officer Representative (COR), Program/Project Manager or other government acceptance official identified in the contract by clicking on the Send More Email Notification link upon submission of an invoice/cost voucher in WAWF-RA. To access WAWF, go to https://wawf.eb.mil//.

 

** For questions, contact the DTRA WAWF Team at 703-767-6840 or wawfhelp@dtra.mil **

 

(b)  Definitions:

 

Acceptor: Contracting Officer’s Representative, Program/Project Manager, or other government acceptance official as identified in the contract/order.

 

Pay Official: Defense Finance and Accounting Service (DFAS) payment office identified in the contract/order.

 

SHIP To/Service Acceptor DoDAAC: Acceptor DoDAAC or DCMA DoDAAC (as specified in the contract/order).

 

DCAA Auditor DoDAAC: Needed when invoicing on cost-reimbursable contracts. (Go to www.dcaa.mil and click on the appropriate link under the Audit Office Locator to search for your DCAA DoDAAC.)

 

>>>                           For contracts that are administered by the Office of Naval Research (ONR):                              <<<

Enter the ONR DoDAAC in the DCAA Auditor DoDAAC field in WAWF.

 

11

 

(c)  WAWF Contractor Input Information:

 

The contractor shall use the following information in creating electronic payment requests in WAWF:

 

Invoice Type in WAWF:

 

If billing for Cost Type/Reimbursable contracts (including T&M and LH), select “Cost Voucher”

If billing for Firm-Fixed Price Materials Only, select “Combo”

If billing for Firm-Fixed Price Materials and Service, select “Combo”

If billing for Firm-Fixed Price Services Only, select “2-n-1 (Services Only)”

 

For WAWF Routing Information, See Table Below:

 

	
Description
    	
 
    	
SF 26
    	
 
    	
SF 33
    	
 
    	
SF 1449
    	
 
    	
DD 1155
    	
 
    
	
 
    	
 
    	
Located   in Block/Section
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Contract   Number
    	
 
    	
2
    	
 
    	
2
    	
 
    	
2
    	
 
    	
1
    	
 
    
	
Delivery   Order
    	
 
    	
See   Individual Order
    	
 
    	
 
    	
 
    	
4
    	
 
    	
2
    	
 
    
	
CAGE   Code
    	
 
    	
7
    	
 
    	
15a
    	
 
    	
17a
    	
 
    	
9
    	
 
    
	
Pay   DoDAAC
    	
 
    	
12
    	
 
    	
25
    	
 
    	
18a
    	
 
    	
15
    	
 
    
	
Inspection
    	
 
    	
Section E   (except SF 1449, See Entitled):
   INSPECTION AND ACCEPTANCE
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Acceptance
    	
 
    	
Section E   (except SF 1449, See Entitled):
   INSPECTION AND ACCEPTANCE
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Issue   Date
    	
 
    	
3
    	
 
    	
5
    	
 
    	
3
    	
 
    	
3
    	
 
    
	
Issue   by DoDAAC
    	
 
    	
5
    	
 
    	
7
    	
 
    	
9
    	
 
    	
6
    	
 
    
	
Admin   DoDAAC
    	
 
    	
6
    	
 
    	
24
    	
 
    	
16
    	
 
    	
7
    	
 
    
	
Ship   To / Service Acceptor DoDAAC
    	
 
    	
6
    	
 
    	
24
    	
 
    	
16
    	
 
    	
7
    	
 
    
	
Ship   to Extension
    	
 
    	
Do Not Fill In
    
	
Services   or Supplies
    	
 
    	
Based   on majority of requirement as determined by monetary value
    
	
Final   Invoice?
    	
 
    	
Do   not change “N” (no) to “Y” (yes) unless this is the last invoice and the   contract is ready for closeout.
    

 

(d)  Final Invoices/Vouchers -Final Payment shall be made in accordance with the Federal Acquisition Regulation (FAR) 52.216-7, entitled “Allowable Cost and Payment.”

 

Invoices - Invoice 2-n-1 (Services Only) and Invoice and Receiving Report (Combo)

Select the “Y” selection from the “Final Invoice?” drop-down box when submitting the final invoice for payment for a contract. Upon successful submission of the final invoice, click on the Send More Email Notifications link to send an additional email notification to the Contracting Officer Representative (COR), Program/Project Manager or other government acceptance official identified in the contract.

 

Cost Vouchers - Once the final DCAA audit is complete for cost reimbursable contracts and authorization is received to submit the final cost voucher, select the “Y” selection from the “Final Voucher” drop-down box when submitting the final cost voucher. Upon successful submission of the final cost voucher, click on the Send More Email Notifications link to send an additional email notification to the following email address: finalcostvouchers@dtra.mil

 

(e)  WAWF Training may be accessed online at http://www.wawftraining.com//. To practice creating documents in WAWF, visit practice site at https://wawftraining.eb.mil//. General DFAS information may be accessed using the DFAS website at http://www.dod.mil/dfas//. Payment status information may be accessed using the myInvoice system at https://myinvoice.csd.disa.mil// or by calling the DFAS Columbus

 

12

 

helpdesk at 800-756-4571. (Select Option 1) Your contract number and shipment/invoice number will be required to check status of your payment. Note: For specific invoice related inquiries email: wawfvendorpay@dtra.mil. Vendors shall forward any additional DTRA related WAWF questions to wawfhelp@dtra.mil.

 

13

 

Section H - Special Contract Requirements

 

H.1 PATENT RIGHTS

RETENTION BY THE CONTRACTOR

 

In accordance with FAR 52.227-11 (f), reporting on utilization of subject inventions:

 

The Contractor agrees to submit, periodic reports annually on the utilization of a subject invention or efforts at obtaining such utilization that are being made by the Contractor or its licensees or assignees.

 

14

 

Section I - Contract Clauses

 

CLAUSES INCORPORATED BY REFERENCE

 

	
52.202-1
    	
 
    	
Definitions
    	
 
    	
JUL 2004
    
	
52.203-3
    	
 
    	
Gratuities
    	
 
    	
APR 1984
    
	
52.203-5
    	
 
    	
Covenant Against Contingent Fees
    	
 
    	
APR 1984
    
	
52.203-6
    	
 
    	
Restrictions On Subcontractor Sales To The   Government
    	
 
    	
SEP 2006
    
	
52.203-7
    	
 
    	
Anti-Kickback Procedures
    	
 
    	
JUL 1995
    
	
52.203-8
    	
 
    	
Cancellation, Rescission, and Recovery of Funds for   Illegal or Improper Activity
    	
 
    	
JAN 1997
    
	
52.203-10
    	
 
    	
Price Or Fee Adjustment For Illegal Or Improper   Activity
    	
 
    	
JAN 1997
    
	
52.203-12
    	
 
    	
Limitation On Payments To Influence Certain Federal   Transactions
    	
 
    	
SEP 2007
    
	
52.203-13
    	
 
    	
Contractor Code of Business Ethics and Conduct
    	
 
    	
DEC 2007
    
	
52.203-14
    	
 
    	
Display of Hotline Poster(s)
    	
 
    	
DEC 2007
    
	
52.204-4
    	
 
    	
Printed or Copied Double-Sided on Recycled Paper
    	
 
    	
AUG 2000
    
	
52.204-7
    	
 
    	
Central Contractor Registration
    	
 
    	
APR 2008
    
	
52.209-6
    	
 
    	
Protecting the Government’s Interest When   Subcontracting With Contractors Debarred, Suspended, or Proposed for   Debarment
    	
 
    	
SEP 2006
    
	
52.215-2
    	
 
    	
Audit and Records—Negotiation
    	
 
    	
JUN 1999
    
	
52.215-8
    	
 
    	
Order of Precedence—Uniform Contract Format
    	
 
    	
OCT 1997
    
	
52.215-10
    	
 
    	
Price Reduction for Defective Cost or Pricing Data
    	
 
    	
OCT 1997
    
	
52.215-12
    	
 
    	
Subcontractor Cost or Pricing Data
    	
 
    	
OCT 1997
    
	
52.215-15
    	
 
    	
Pension Adjustments and Asset Reversions
    	
 
    	
OCT 2004
    
	
52.215-17
    	
 
    	
Waiver of Facilities Capital Cost of Money
    	
 
    	
OCT 1997
    
	
52.215-18
    	
 
    	
Reversion or Adjustment of Plans for Postretirement   Benefits (PRB) Other than Pensions
    	
 
    	
JUL 2005
    
	
52.215-19
    	
 
    	
Notification of Ownership Changes
    	
 
    	
OCT 1997
    
	
52.216-7
    	
 
    	
Allowable Cost And Payment
    	
 
    	
DEC 2002
    
	
52.216-8
    	
 
    	
Fixed Fee
    	
 
    	
MAR 1997
    
	
52.217-9
    	
 
    	
Option To Extend The Term Of The Contract
    	
 
    	
MAR 2000
    
	
52.219-8
    	
 
    	
Utilization of Small Business Concerns
    	
 
    	
MAY 2004
    
	
52.219-28
    	
 
    	
Post-Award Small Business Program Rerepresentation
    	
 
    	
JUN 2007
    
	
52.222-3
    	
 
    	
Convict Labor
    	
 
    	
JUN 2003
    
	
52.222-21
    	
 
    	
Prohibition Of Segregated Facilities
    	
 
    	
FEB 1999
    
	
52.222-26
    	
 
    	
Equal Opportunity
    	
 
    	
MAR 2007
    
	
52.222-35
    	
 
    	
Equal Opportunity For Special Disabled Veterans,   Veterans of the Vietnam Era, and Other Eligible Veterans
    	
 
    	
SEPT 2006
    
	
52.222-36
    	
 
    	
Affirmative Action For Workers With Disabilities
    	
 
    	
JUN 1998
    
	
52.222-37
    	
 
    	
Employment Reports On Special Disabled Veterans,   Veterans Of The Vietnam Era, and Other Eligible Veterans
    	
 
    	
SEPT 2006
    
	
52.222-39
    	
 
    	
Notification of Employee Rights Concerning Payment   of Union Dues or Fees
    	
 
    	
DEC 2004
    
	
52.222-50
    	
 
    	
Combating Trafficking in Persons
    	
 
    	
AUG 2007
    
	
52.223-6
    	
 
    	
Drug-Free Workplace
    	
 
    	
MAY 2001
    
	
52.223-14
    	
 
    	
Toxic Chemical Release Reporting
    	
 
    	
AUG 2003
    
	
52.225-13
    	
 
    	
Restrictions on Certain Foreign Purchases
    	
 
    	
JUN 2008
    
	
52.227-1 Alt I
    	
 
    	
Authorization And Consent (Dec 2007) - Alternate I
    	
 
    	
APR 1984
    
	
52.227-2
    	
 
    	
Notice And Assistance Regarding Patent And Copyright   Infringement
    	
 
    	
DEC 2007
    
	
52.227-11 Alt II
    	
 
    	
Patent Rights—Ownership by the Contractor (Dec 2007)   — Alternate II
    	
 
    	
DEC 2007
    
	
52.228-7
    	
 
    	
Insurance—Liability To Third Persons
    	
 
    	
MAR 1996
    
	
52.232-9
    	
 
    	
Limitation On Withholding Of Payments
    	
 
    	
APR 1984
    
	
52.232-17
    	
 
    	
Interest
    	
 
    	
JUN 1996
    

 

15

 

	
52.232-20
    	
 
    	
Limitation Of Cost
    	
 
    	
APR 1984
    
	
52.232-23 Alt I
    	
 
    	
Assignment of Claims (Jan 1986) - Alternate I
    	
 
    	
APR 1984
    
	
52.232-25 Alt I
    	
 
    	
Prompt Payment (Oct 2003) Alternate I
    	
 
    	
FEB 2002
    
	
52.232-33
    	
 
    	
Payment by Electronic Funds Transfer—Central   Contractor Registration
    	
 
    	
OCT 2003
    
	
52.233-1 Alt I
    	
 
    	
Disputes (Jul 2002) - Alternate I
    	
 
    	
DEC 1991
    
	
52.233-3 Alt I
    	
 
    	
Protest After Award (Aug 1996) - Alternate I
    	
 
    	
JUN 1985
    
	
52.233-4
    	
 
    	
Applicable Law for Breach of Contract Claim
    	
 
    	
OCT 2004
    
	
52.242-1
    	
 
    	
Notice of Intent to Disallow Costs
    	
 
    	
APR 1984
    
	
52.242-3
    	
 
    	
Penalties for Unallowable Costs
    	
 
    	
MAY 2001
    
	
52.242-4
    	
 
    	
Certification of Final Indirect Costs
    	
 
    	
JAN 1997
    
	
52.242-13
    	
 
    	
Bankruptcy
    	
 
    	
JUL 1995
    
	
52.243-2 Alt V
    	
 
    	
Changes—Cost-Reimbursement (Aug 1987) - Alternate V
    	
 
    	
APR 1984
    
	
52.244-2
    	
 
    	
Subcontracts
    	
 
    	
JUN 2007
    
	
52.244-5
    	
 
    	
Competition In Subcontracting
    	
 
    	
DEC 1996
    
	
52.244-6
    	
 
    	
Subcontracts for Commercial Items
    	
 
    	
MAR 2007
    
	
52.245-1
    	
 
    	
Government Property
    	
 
    	
JUN 2007
    
	
52.245-9
    	
 
    	
Use And Charges
    	
 
    	
JUN 2007
    
	
52.246-9
    	
 
    	
Inspection Of Research And Development (Short Form)
    	
 
    	
APR 1984
    
	
52.246-25
    	
 
    	
Limitation Of Liability—Services
    	
 
    	
FEB 1997
    
	
52.249-6
    	
 
    	
Termination (Cost Reimbursement)
    	
 
    	
MAY 2004
    
	
52.251-1
    	
 
    	
Government Supply Sources
    	
 
    	
APR 1984
    
	
52.253-1
    	
 
    	
Computer Generated Forms
    	
 
    	
JAN 1991
    
	
252.203-7000
    	
 
    	
Requirements Relating to Compensation of Former DoD   Officials
    	
 
    	
JAN 2009
    
	
252.203-7001
    	
 
    	
Prohibition On Persons Convicted of Fraud or Other   Defense-Contract-Related Felonies
    	
 
    	
DEC 2004
    
	
252.203-7002
    	
 
    	
Requirement to Inform Employees of Whistleblower   Rights
    	
 
    	
JAN 2009
    
	
252.204-7000
    	
 
    	
Disclosure Of Information
    	
 
    	
DEC 1991
    
	
252.204-7003
    	
 
    	
Control Of Government Personnel Work Product
    	
 
    	
APR 1992
    
	
252.204-7004 Alt A
    	
 
    	
Central Contractor Registration (52.204-7) Alternate   A
    	
 
    	
SEP 2007
    
	
252.204-7009
    	
 
    	
Requirements Regarding Potential Access to   Export-Controlled Items
    	
 
    	
JUL 2008
    
	
252.205-7000
    	
 
    	
Provision Of Information To Cooperative Agreement   Holders
    	
 
    	
DEC 1991
    
	
252.209-7004
    	
 
    	
Subcontracting With Firms That Are Owned or   Controlled By The Government of a Terrorist Country
    	
 
    	
DEC 2006
    
	
252.211-7007
    	
 
    	
Reporting of Government-Furnished Equipment in the   DoD Item Unique Identification (IUID) Registry
    	
 
    	
NOV 2008
    
	
252.215-7000
    	
 
    	
Pricing Adjustments
    	
 
    	
DEC 1991
    
	
252.215-7002
    	
 
    	
Cost Estimating System Requirements
    	
 
    	
DEC 2006
    
	
252.215-7004
    	
 
    	
Excessive Pass-Through Charges
    	
 
    	
MAY 2008
    
	
252.225-7006
    	
 
    	
Quarterly Reporting of Actual Contract Performance   Outside the United States
    	
 
    	
MAY 2007
    
	
252.225-7012
    	
 
    	
Preference For Certain Domestic Commodities
    	
 
    	
MAR 2008
    
	
252.226-7001
    	
 
    	
Utilization of Indian Organizations and Indian-Owned   Economic Enterprises, and Native Hawaiian Small Business Concerns
    	
 
    	
SEP 2004
    
	
252.227-7013
    	
 
    	
Rights in Technical Data—Noncommercial Items
    	
 
    	
NOV 1995
    
	
252.227-7016
    	
 
    	
Rights in Bid or Proposal Information
    	
 
    	
JUN 1995
    
	
252.227-7025
    	
 
    	
Limitations on the Use or Disclosure of Government-   Furnished Information Marked with Restrictive Legends
    	
 
    	
JUN 1995
    
	
252.227-7027
    	
 
    	
Deferred Ordering Of Technical Data Or Computer   Software
    	
 
    	
APR 1988
    
	
252.227-7030
    	
 
    	
Technical Data—Withholding Of Payment
    	
 
    	
MAR 2000
    
	
252.227-7037
    	
 
    	
Validation of Restrictive Markings on Technical Data
    	
 
    	
SEP 1999
    
	
252.227-7039
    	
 
    	
Patents—Reporting Of Subject Inventions
    	
 
    	
APR 1990
    
	
252.231-7000
    	
 
    	
Supplemental Cost Principles
    	
 
    	
DEC 1991
    
	
252.232-7003
    	
 
    	
Electronic Submission of Payment Requests and   Receiving Reports
    	
 
    	
MAR 2008
    

 

16

 

	
252.232-7010
    	
 
    	
Levies on Contract Payments
    	
 
    	
DEC 2006
    
	
252.235-7002
    	
 
    	
Animal Welfare
    	
 
    	
DEC 1991
    
	
252.235-7010
    	
 
    	
Acknowledgment of Support and Disclaimer
    	
 
    	
MAY 1995
    
	
252.235-7011
    	
 
    	
Final Scientific or Technical Report
    	
 
    	
NOV 2004
    
	
252.243-7002
    	
 
    	
Requests for Equitable Adjustment
    	
 
    	
MAR 1998
    
	
252.244-7000
    	
 
    	
Subcontracts for Commercial Items and Commercial   Components (DoD Contracts)
    	
 
    	
JAN 2007
    
	
252.247-7023
    	
 
    	
Transportation of Supplies by Sea
    	
 
    	
MAY 2002
    
	
252.247-7024
    	
 
    	
Notification Of Transportation Of Supplies By Sea
    	
 
    	
MAR 2000
    
	
252.251-7000
    	
 
    	
Ordering From Government Supply Sources
    	
 
    	
NOV 2004
    

 

CLAUSES INCORPORATED BY FULL TEXT

 

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

 

(a)  The Government may extend the term of this contract by written notice to the Contractor on or before the expiration of the contract basic period. The Government will give the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

 

(b)  If the Government exercises this option, the extended contract shall be considered to include this option clause.

 

(c)  The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36-Months.

 

(End of clause)

 

52.222-2 PAYMENT FOR OVERTIME PREMIUMS (JUL 1990)

 

(a)  The use of overtime is authorized under this contract if the overtime premium cost does not exceed $0.00 or the overtime premium is paid for work —

 

(1)  Necessary to cope with emergencies such as those resulting from accidents, natural disasters, breakdowns of production equipment, or occasional production bottlenecks of a sporadic nature;

 

(2)  By indirect-labor employees such as those performing duties in connection with administration, protection, transportation, maintenance, standby plant protection, operation of utilities, or accounting;

 

(3)  To perform tests, industrial processes, laboratory procedures, loading or unloading of transportation conveyances, and operations in flight or afloat that are continuous in nature and cannot reasonably be interrupted or completed otherwise; or

 

(4) That will result in lower overall costs to the Government.

 

(b)  Any request for estimated overtime premiums that exceeds the amount specified above shall include all estimated overtime for contract completion and shall—

 

17

 

(1)  Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime;

 

(2)  Demonstrate the effect that denial of the request will have on the contract delivery or performance schedule;

 

(3)  Identify the extent to which approval of overtime would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and

 

(4)  Provide reasons why the required work cannot be performed by using multishift operations or by employing additional personnel.

 

* Insert either “zero” or the dollar amount agreed to during negotiations. The inserted figure does not apply to the exceptions in paragraph (a)(1) through (a)(4) of the clause.

 

(End of clause)

 

52.249-14 EXCUSABLE DELAYS (APR 1984)

 

(a)  Except for defaults of subcontractors at any tier, the Contractor shall not be in default because of any failure to perform this contract under its terms if the failure arises from causes beyond the control and without the fault or negligence of the Contractor. Examples of these causes are (1) acts of God or of the public enemy, (2) acts of the Government in either its sovereign or contractual capacity, (3) fires, (4) floods, (5) epidemics, (6) quarantine restrictions, (7) strikes, (8) freight embargoes, and (9) unusually severe weather. In each instance, the failure to perform must be beyond the control and without the fault or negligence of the Contractor. “Default” includes failure to make progress in the work so as to endanger performance.

 

(b)  If the failure to perform is caused by the failure of a subcontractor at any tier to perform or make progress, and if the cause of the failure was beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either, the Contractor shall not be deemed to be in default, unless—

 

(1)  The subcontracted supplies or services were obtainable from other sources;

 

(2)  The Contracting Officer ordered the Contractor in writing to purchase these supplies or services from the other source; and

 

(3)  The Contractor failed to comply reasonably with this order.

 

(c)  Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of the failure. If the Contracting Officer determines that any failure to perform results from one or more of the causes above, the delivery schedule shall be revised, subject to the rights of the Government under the termination clause of this contract.

 

(End of clause)

 

18

 

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

 

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

 

http://farsite.hill.af.mil/

 

(End of clause)

 

252.201-9003 LIMITATION OF AUTHORITY

 

No person in the Government, other than a Contracting Officer, has the authority to provide direction to the Contractor, which alters the Contractor’s obligations or changes this contract in any way. If any person representing the Government, other than a Contracting Officer, attempts to alter contract obligations, change the contract specifications/statement of work or tells the contractor to perform some effort which the Contractor believes to be outside the scope of this contract, the Contractor shall immediately notify the Procuring Contracting Officer (PCO). Contractor personnel shall not comply with any order or direction which they believe to be outside the scope of this contract unless the order or direction is issued by a Contracting Officer.

 

252.203-9004 ETIOLOGIC AGENTS — BIOLOGICAL DEFENSE RESEARCH PROGRAM (FEB 2008)

 

a.               For purpose of this contract etiologic agent—biological defense program is defined as: any viable microorganism, or its toxin which causes or may cause human disease, including those agents listed in 42 CFR 73, 9 CFR 121, and 7 CFR 331, of the Department of Health and Human Services and Department of Agriculture regulations, respectively, and any agent of biological origin that poses a degree of hazard to those agents and is further identified by the US Army. The contractor shall comply with the following when working with etiologic agents:

 

(1)                      29 Code of Federal Regulations 1910, Occupational Health and Safety;

(2)                      US Department of Health and Human Services (DHHS) and US Department of Agriculture, Select Agent Program(s), 42 CFR 73, 9 CFR 121, and 7 CFR 331; and

(3)                      DHHS Publication No. 93-8395, Biosafety in Microbiological and Biomedical Laboratories, latest edition.

 

b.              Etiologic agents shall be packaged, labeled, shipped, and transported in accordance with applicable Federal, State, and local laws and regulations, to include:

 

(1)                      42 CFR 72 (Interstate Shipment of Etiologic Agents);

(2)                      49 CFR 172 and 173 (Department of Transportation);

(3)                      9 CFR 122 (USDA Restricted Animal Pathogens);

(4)                      International Air Transport Association Dangerous Goods Regulations;

(5)                      The United States Postal Service shall not be used for transportation of BDRP related etiologic agents; and

(6)                      If performance is outside of the United States, any additional procedures required by the nation where the work is to be performed.

 

19

 

252.204-9004 IMPLEMENTATION OF DISCLOSURE OF INFORMATION (JUN 2007)

 

In accordance with DFARS 252.204-7000 Disclosure of Information, any information to be released shall be submitted at least 45 days before the proposed release date, for security and policy review. Submit one copy to each below:

 

(a)  Office of Public Affairs, DTRA/DIR/COS/PA, 8725 John J. Kingman Dr, MS 6201, Ft Belvoir VA 22060-6201.

(b)  Contracting Officer

(c)  Program Manager

(d)  Task Order Manager

 

(End of Clause)

 

252.209-9002 NON-GOVERNMENT SUPPORT PERSONNEL (JAN 2008)

 

The following companies may have access to contractor information, technical data or computer software that may be marked as proprietary or otherwise marked with restrictive legends: Suntiva LLC (Formerly C-Systems International Corporation)(contract specialist support); Systems Research and Analysis (SRA, managing JPRAS)and The Tauri Group (Advisory and Assistance Services). Each contract contains organizational conflict of interest provisions and/or includes contractual requirements for non-disclosure of proprietary contractor information or data/software marked with restrictive legends. The contractor, by submitting a proposal or entering into this contract, is deemed to have consented to the disclosure of its information to Suntiva LLC, SRA, and The Tauri Group under the conditions and limitations described herein.

 

252.215-9004 KEY PERSONNEL (FEB 2000)

 

The personnel listed below are considered essential to the work being performed hereunder. Prior to removing, replacing, or diverting any of the specified individuals, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on this Contract. No deviation shall be made by the Contractor without the prior written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing the change, such ratification shall constitute the consent of the Contracting Officer required by this paragraph. The personnel listed below may, with the consent of the contracting parties, be amended from time to time during the course of the Contract to either add or delete personnel as appropriate.

 

Principal Investigator

 

252.216-9003 CONSULTANTS (OCT 1998)

 

Services of consultants shall be at rates and for periods approved in advance by the Contracting Officer. Requests for approval shall be submitted to the Contracting Officer sufficiently in advance of the need to use a consultant under this Contract. The request shall include (a) a copy of the proposed consultant agreement, (b) a brief biography of the consultant, and (c) an indication of the area(s) in which consultant’s expertise will be utilized and why it is essential for contract performance. In addition, significant deviations from the dollar amount approved for consultant services, or changes in the

 

20

 

consultants to be utilized, must likewise be approved in advance upon submission of adequate justification.

 

252.227-7013 RIGHTS IN TECHNICAL DATA—NONCOMMERCIAL ITEMS. (NOV 1995)

 

(a)  Definitions. As used in this clause:

 

(1)  Computer data base means a collection of data recorded in a form capable of being processed by a computer. The term does not include computer software.

 

(2)  Computer program means a set of instructions, rules, or routines recorded in a form that is capable of causing a computer to perform a specific operation or series of operations.

 

(3)  Computer software means computer programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae and related material that would enable the software to be reproduced, recreated, or recompiled. Computer software does not include computer data bases or computer software documentation.

 

(4)  Computer software documentation means owner’s manuals, user’s manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

 

(5)  Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

 

(6)  Developed means that an item, component, or process exists and is workable. Thus, the item or component must have been constructed or the process practiced. Workability is generally established when the item, component, or process has been analyzed or tested sufficiently to demonstrate to reasonable people skilled in the applicable art that there is a high probability that it will operate as intended. Whether, how much, and what type of analysis or testing is required to establish workability depends on the nature of the item, component, or process, and the state of the art. To be considered “developed,” the item, component, or process need not be at the stage where it could be offered for sale or sold on the commercial market, nor must the item, component, or process be actually reduced to practice within the meaning of Title 35 of the United States Code.

 

(7)  Developed exclusively at private expense means development was accomplished entirely with costs charged to indirect cost pools, costs not allocated to a government contract, or any combination thereof.

 

(i)  Private expense determinations should be made at the lowest practicable level.

 

(ii)  Under fixed-price contracts, when total costs are greater than the firm-fixed-price or ceiling price of the contract, the additional development costs necessary to complete development shall not be considered when determining whether development was at government, private, or mixed expense.

 

(8)  Developed exclusively with government funds means development was not accomplished exclusively or partially at private expense.

 

(9)  Developed with mixed funding means development was accomplished partially with costs charged to indirect cost pools and/or costs not allocated to a government contract, and partially with costs charged directly to a government contract.

 

21

 

(10)  Form, fit, and function data means technical data that describes the required overall physical, functional, and performance characteristics (along with the qualification requirements, if applicable) of an item, component, or process to the extent necessary to permit identification of physically and functionally interchangeable items.

 

(11)  Government purpose means any activity in which the United States Government is a party, including cooperative agreements with international or multi-national defense organizations, or sales or transfers by the United States Government to foreign governments or international organizations. Government purposes include competitive procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose technical data for commercial purposes or authorize others to do so.

 

(12)  Government purpose rights means the rights to—

 

(i)  Use, modify, reproduce, release, perform, display, or disclose technical data within the Government without restriction; and

 

(ii)  Release or disclose technical data outside the Government and authorize persons to whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States government purposes.

 

(13)  Limited rights means the rights to use, modify, reproduce, release, perform, display, or disclose technical data, in whole or in part, within the Government. The Government may not, without the written permission of the party asserting limited rights, release or disclose the technical data outside the Government, use the technical data for manufacture, or authorize the technical data to be used by another party, except that the Government may reproduce, release or disclose such data or authorize the use or reproduction of the data by persons outside the Government if reproduction, release, disclosure, or use is—

 

(i)  Necessary for emergency repair and overhaul; or

 

(ii)  A release or disclosure of technical data (other than detailed manufacturing or process data) to, or use of such data by, a foreign government that is in the interest of the Government and is required for evaluational or informational purposes;

 

(iii)  Subject to a prohibition on the further reproduction, release, disclosure, or use of the technical data; and

 

(iv)  The contractor or subcontractor asserting the restriction is notified of such reproduction, release, disclosure, or use.

 

(14)  Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

 

(15)  Unlimited rights means rights to use, modify, reproduce, perform, display, release, or disclose technical data in whole or in part, in any manner, and for any purpose whatsoever, and to have or authorize others to do so.

 

(b)  Rights in technical data. The Contractor grants or shall obtain for the Government the following royalty free, world-wide, nonexclusive, irrevocable license rights in technical data other than computer software documentation (see the Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation clause of this contract for rights in computer software documentation):

 

22

 

(1)  Unlimited rights.

 

The Government shall have unlimited rights in technical data that are—

 

(i)  Data pertaining to an item, component, or process which has been or will be developed exclusively with Government funds;

 

(ii)  Studies, analyses, test data, or similar data produced for this contract, when the study, analysis, test, or similar work was specified as an element of performance;

 

(iii)  Created exclusively with Government funds in the performance of a contract that does not require the development, manufacture, construction, or production of items, components, or processes;

 

(iv)  Form, fit, and function data;

 

(v)  Necessary for installation, operation, maintenance, or training purposes (other than detailed manufacturing or process data);

 

(vi)  Corrections or changes to technical data furnished to the Contractor by the Government;

 

(vii)  Otherwise publicly available or have been released or disclosed by the Contractor or subcontractor without restrictions on further use, release or disclosure, other than a release or disclosure resulting from the sale, transfer, or other assignment of interest in the technical data to another party or the sale or transfer of some or all of a business entity or its assets to another party;

 

(viii)  Data in which the Government has obtained unlimited rights under another Government contract or as a result of negotiations; or

 

(ix)  Data furnished to the Government, under this or any other Government contract or subcontract thereunder, with —

 

(A)  Government purpose license rights or limited rights and the restrictive condition(s) has/have expired; or

 

(B)  Government purpose rights and the Contractor’s exclusive right to use such data for commercial purposes has expired.

 

(2)  Government purpose rights.

 

(i)  The Government shall have government purpose rights for a five-year period, or such other period as may be negotiated, in technical data—

 

(A)  That pertain to items, components, or processes developed with mixed funding except when the Government is entitled to unlimited rights in such data as provided in paragraphs (b)(ii) and (b)(iv) through (b)(ix) of this clause; or

 

(B)  Created with mixed funding in the performance of a contract that does not require the development, manufacture, construction, or production of items, components, or processes.

 

(ii)  The five-year period, or such other period as may have been negotiated, shall commence upon execution of the contract, subcontract, letter contract (or similar contractual instrument), contract modification, or option exercise that required development of the items, components, or processes or creation of the data described in paragraph (b)(2)(i)(B) of this clause. Upon expiration of the five-year or other negotiated period, the Government shall have unlimited rights in the technical data.

 

23

 

(iii)  The Government shall not release or disclose technical data in which it has government purpose rights unless-

 

(A)  Prior to release or disclosure, the intended recipient is subject to the non-disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement (DFARS); or

 

(B)  The recipient is a Government contractor receiving access to the data for performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends.

 

(iv)  The Contractor has the exclusive right, including the right to license others, to use technical data in which the Government has obtained government purpose rights under this contract for any commercial purpose during the time period specified in the government purpose rights legend prescribed in paragraph (f)(2) of this clause.

 

(3)  Limited rights.

 

(i)  Except as provided in paragraphs (b)(1)(ii) and (b)(1)(iv) through (b)(1)(ix) of this clause, the Government shall have limited rights in technical data—

 

(A)  Pertaining to items, components, or processes developed exclusively at private expense and marked with the limited rights legend prescribed in paragraph (f) of this clause; or

 

(B)  Created exclusively at private expense in the performance of a contract that does not require the development, manufacture, construction, or production of items, components, or processes.

 

(ii)  The Government shall require a recipient of limited rights data for emergency repair or overhaul to destroy the data and all copies in its possession promptly following completion of the emergency repair/overhaul and to notify the Contractor that the data have been destroyed.

 

(iii)  The Contractor, its subcontractors, and suppliers are not required to provide the Government additional rights to use, modify, reproduce, release, perform, display, or disclose technical data furnished to the Government with limited rights. However, if the Government desires to obtain additional rights in technical data in which it has limited rights, the Contractor agrees to promptly enter into negotiations with the Contracting Officer to determine whether there are acceptable terms for transferring such rights. All technical data in which the Contractor has granted the Government additional rights shall be listed or described in a license agreement made part of the contract. The license shall enumerate the additional rights granted the Government in such data.

 

(4)  Specifically negotiated license rights.

 

The standard license rights granted to the Government under paragraphs (b)(1) through (b)(3) of this clause, including the period during which the Government shall have government purpose rights in technical data, may be modified by mutual agreement to provide such rights as the parties consider appropriate but shall not provide the Government lesser rights than are enumerated in paragraph (a)(13) of this clause. Any rights so negotiated shall be identified in a license agreement made part of this contract.

 

(5)  Prior government rights.

 

Technical data that will be delivered, furnished, or otherwise provided to the Government under this contract, in which the Government has previously obtained rights shall be delivered, furnished, or provided with the pre-existing rights, unless—

 

24

 

(i)  The parties have agreed otherwise; or

 

(ii)  Any restrictions on the Government’s rights to use, modify, reproduce, release, perform, display, or disclose the data have expired or no longer apply.

 

(6)  Release from liability.

 

The Contractor agrees to release the Government from liability for any release or disclosure of technical data made in accordance with paragraph (a)(13) or (b)(2)(iii) of this clause, in accordance with the terms of a license negotiated under paragraph (b)(4) of this clause, or by others to whom the recipient has released or disclosed the data and to seek relief solely from the party who has improperly used, modified, reproduced, released, performed, displayed, or disclosed Contractor data marked with restrictive legends.

 

(c)  Contractor rights in technical data. All rights not granted to the Government are retained by the Contractor.

 

(d)  Third party copyrighted data. The Contractor shall not, without the written approval of the Contracting Officer, incorporate any copyrighted data in the technical data to be delivered under this contract unless the Contractor is the copyright owner or has obtained for the Government the license rights necessary to perfect a license or licenses in the deliverable data of the appropriate scope set forth in paragraph (b) of this clause, and has affixed a statement of the license or licenses obtained on behalf of the Government and other persons to the data transmittal document.

 

(e)  Identification and delivery of data to be furnished with restrictions on use, release, or disclosure. (1) This paragraph does not apply to restrictions based solely on copyright.

 

(2)  Except as provided in paragraph (e)(3) of this clause, technical data that the Contractor asserts should be furnished to the Government with restrictions on use, release, or disclosure are identified in an attachment to this contract (the Attachment). The Contractor shall not deliver any data with restrictive markings unless the data are listed on the Attachment.

 

(3)  In addition to the assertions made in the Attachment, other assertions may be identified after award when based on new information or inadvertent omissions unless the inadvertent omissions would have materially affected the source selection decision. Such identification and assertion shall be submitted to the Contracting Officer as soon as practicable prior to the scheduled date for delivery of the data, in the following format, and signed by an official authorized to contractually obligate the Contractor: Identification and Assertion of Restrictions on the Government’s Use, Release, or Disclosure of Technical Data.

 

The Contractor asserts for itself, or the persons identified below, that the Government’s rights to use, release, or disclose the following technical data should be restricted—

 

	
Technical data
    to be Furnished
    With Restrictions (1)
    	
 
    	
Basis for
    Assertion (2)
    	
 
    	
Asserted
    Rights
    Category (3)
    	
 
    	
Name of Person
    Asserting
    Restrictions (4)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
(LIST)
    	
 
    	
(LIST)
    	
 
    	
(LIST)
    	
 
    	
(LIST)
    

 

(1) If the assertion is applicable to items, components or processes developed at private expense, identify both the data and each such items, component, or process.

 

(2) Generally, the development of an item, component, or process at private expense, either exclusively or partially, is the only basis for asserting restrictions on the Government’s rights to use, release, or

 

25

 

disclose technical data pertaining to such items, components, or processes. Indicate whether development was exclusively or partially at private expense. If development was not at private expense, enter the specific reason for asserting that the Government’s rights should be restricted.

 

(3) Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data generated under another contract, limited or government purpose rights under this or a prior contract, or specifically negotiated licenses).

 

(4) Corporation, individual, or other person, as appropriate.

 

	
Date
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Printed Name and Title
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Signature
    	
 
    	
 
    
						

 

(End of identification and assertion)

 

(4)  When requested by the Contracting Officer, the Contractor shall provide sufficient information to enable the Contracting Officer to evaluate the Contractor’s assertions. The Contracting Officer reserves the right to add the Contractor’s assertions to the Attachment and validate any listed assertion, at a later date, in accordance with the procedures of the Validation of Restrictive Markings on Technical Data clause of this contract.

 

(f)  Marking requirements. The Contractor, and its subcontractors or suppliers, may only assert restrictions on the Government’s rights to use, modify, reproduce, release, perform, display, or disclose technical data to be delivered under this contract by marking the deliverable data subject to restriction. Except as provided in paragraph (f)(5) of this clause, only the following legends are authorized under this contract: the government purpose rights legend at paragraph (f)(2) of this clause; the limited rights legend at paragraph (f)(3) of this clause; or the special license rights legend at paragraph (f)(4) of this clause; and/or a notice of copyright as prescribed under 17 U.S.C. 401 or 402.

 

(1)  General marking instructions. The Contractor, or its subcontractors or suppliers, shall conspicuously and legibly mark the appropriate legend on all technical data that qualify for such markings. The authorized legends shall be placed on the transmittal document or storage container and, for printed material, each page of the printed material containing technical data for which restrictions are asserted. When only portions of a page of printed material are subject to the asserted restrictions, such portions shall be identified by circling, underscoring, with a note, or other appropriate identifier. Technical data transmitted directly from one computer or computer terminal to another shall contain a notice of asserted restrictions. Reproductions of technical data or any portions thereof subject to asserted restrictions shall also reproduce the asserted restrictions.

 

(2)  Government purpose rights markings. Data delivered or otherwise furnished to the Government purpose rights shall be marked as follows:

 

Government Purpose Rights

 

Contract No.

 

Contractor Name

 

Contractor Address

 

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Expiration Date

 

The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these technical data are restricted by paragraph (b)(2) of the Rights in Technical Data—Noncommercial Items clause contained in the above identified contract. No restrictions apply after the expiration date shown above. Any reproduction of technical data or portions thereof marked with this legend must also reproduce the markings.

 

(End of legend)

 

(3)  Limited rights markings. Data delivered or otherwise furnished to the Government with limited rights shall be marked with the following legend:

 

Limited Rights

 

Contract No.

 

Contractor Name

 

Contractor Address

 

 

The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these technical data are restricted by paragraph (b)(3) of the Rights in ,Technical Data—Noncommercial Items clause contained in the above identified contract. Any reproduction of technical data or portions thereof marked with this legend must also reproduce the markings. Any person, other than the Government, who has been provided access to such data must promptly notify the above named Contractor.

 

(End of legend)

 

(4)  Special license rights markings. (i) Data in which the Government’s rights stem from a specifically negotiated license shall be marked with the following legend:

 

Special License Rights

 

The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these data are restricted by Contract No.            (Insert contract number)                   , License No.                        (Insert license identifier)           . Any reproduction of technical data or portions thereof marked with this legend must also reproduce the markings.

 

(End of legend)

 

(ii)  For purposes of this clause, special licenses do not include government purpose license rights acquired under a prior contract (see paragraph (b)(5) of this clause).

 

(5)  Pre-existing data markings. If the terms of a prior contract or license permitted the Contractor to restrict the Government’s rights to use, modify, reproduce, release, perform, display, or disclose technical data deliverable under this contract, and those restrictions are still applicable, the Contractor may mark such data with the appropriate restrictive legend for which the data qualified under the prior contract or license. The marking procedures in paragraph (f)(1) of this clause shall be followed.

 

27

 

(g)  Contractor procedures and records. Throughout performance of this contract, the Contractor and its subcontractors or suppliers that will deliver technical data with other than unlimited rights, shall—

 

(1)  Have, maintain, and follow written procedures sufficient to assure that restrictive markings are used only when authorized by the terms of this clause; and

 

(2)  Maintain records sufficient to justify the validity of any restrictive markings on technical data delivered under this contract.

 

(h)  Removal of unjustified and nonconforming markings. (1) Unjustified technical data markings. The rights and obligations of the parties regarding the validation of restrictive markings on technical data furnished or to be furnished under this contract are contained in the Validation of Restrictive Markings on Technical Data clause of this contract. Notwithstanding any provision of this contract concerning inspection and acceptance, the Government may ignore or, at the Contractor’s expense, correct or strike a marking if, in accordance with the procedures in the Validation of Restrictive Markings on Technical Data clause of this contract, a restrictive marking is determined to be unjustified.

 

(2)  Nonconforming technical data markings. A nonconforming marking is a marking placed on technical data delivered or otherwise furnished to the Government under this contract that is not in the format authorized by this contract. Correction of nonconforming markings is not subject to the validation of Restrictive Markings on Technical Data clause of this contract. If the Contracting Officer notifies the Contractor of a nonconforming marking and the Contractor fails to remove or correct such marking within sixty (60) days, the Government may ignore or, at the Contractor’s expense, remove or correct any nonconforming marking.

 

(i)  Relation to patents. Nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government under any patent.

 

(j)  Limitation on charges for rights in technical data. (1) The Contractor shall not charge to this contract any cost, including, but not limited to, license fees, royalties, or similar charges, for rights in technical data to be delivered under this contract when—

 

(i)  The Government has acquired, by any means, the same or greater rights in the data; or

 

(ii)  The data are available to the public without restrictions.

 

(2)  The limitation in paragraph (j)(1) of this clause—

 

(i)  Includes costs charged by a subcontractor or supplier, at any tier, or costs incurred by the Contractor to acquire rights in subcontractor or supplier technical data, if the subcontractor or supplier has been paid for such rights under any other Government contract or under a license conveying the rights to the Government; and

 

(ii)  Does not include the reasonable costs of reproducing, handling, or mailing the documents or other media in which the technical data will be delivered.

 

(k)  Applicability to subcontractors or suppliers. (1) The Contractor shall ensure that the rights afforded its subcontractors and suppliers under 10 U.S.C. 2320, 10 U.S.C. 2321, and the identification, assertion, and delivery processes of paragraph (e) of this clause are recognized and protected.

 

(2)  Whenever any technical data for noncommercial items is to be obtained from a subcontractor or supplier for delivery to the Government under this contract, the Contractor shall use this same clause in the subcontract or other contractual instrument, and require its subcontractors or suppliers to do so,

 

28

 

without alteration, except to identify the parties. No other clause shall be used to enlarge or diminish the Government’s, the Contractor’s, or a higher-tier subcontractor’s or supplier’s rights in a subcontractor’s or supplier’s technical data.

 

(3)  Technical data required to be delivered by a subcontractor or supplier shall normally be delivered to the next higher-tier contractor, subcontractor, or supplier. However, when there is a requirement in the prime contract for data which may be submitted with other than unlimited rights by a subcontractor or supplier, then said subcontractor or supplier may fulfill its requirement by submitting such data directly to the Government, rather than through a higher-tier contractor, subcontractor, or supplier.

 

(4)  The Contractor and higher-tier subcontractors or suppliers shall not use their power to award contracts as economic leverage to obtain rights in technical data from their subcontractors or suppliers. (5) In no event shall the Contractor use its obligation to recognize and protect subcontractor or supplier rights in technical data as an excuse for failing to satisfy its contractual obligations to the Government.

 

(End of clause)

 

252.227-9000 COMPUTER CODE DEVELOPMENT (OCT 1998)

 

Computer code development (the writing of a new computer program or the enhancement of an existing program to expand its capabilities) even if not explicitly specified in the Tasks of the SOW, shall be accompanied by a report which will be a brief summary describing the software, associated machine requirements and development and documentation status of each Computer Code for DTRA to determine the applicability of the Computer program to specific research programs.

 

252.235-9000 SOURCES OF INFORMATION (JULY 2000)

 

a.  The results of the research to be delivered to the Government under this Contract shall embody the most recent reliable information in the field which is available to the Contractor from private and governmental sources, and the Contractor agrees to utilize all sources of such information available to it. In this connection, information in this field which is in the control of DTRA shall, with the consent of the Contracting Officer’s Representative (COR) and under such safeguards and procedures as he/she may prescribe, be made available to the Contractor on request. Additionally, the Contractor is encouraged to make use of the resources available through the Defense Threat Reduction Information Analysis Center (DTRIAC), 1680 Texas Street, Southeast, Kirtland AFB, New Mexico 87117.

 

b.  Reasonable assistance in obtaining access to information, or in obtaining permission to use Government or private facilities, will be given to the Contractor by DTRA. Specifically, the Contractor must register with the Defense Technical Information Center, ATTN: DTIC, 8725 John J. Kingman Road, Suite 0944, Fort Belvoir, VA 22060-6218, in accordance with Defense Logistics Agency (DLA) Regulation 4185.10, Certification and Registration for Access to DoD Defense Technical Information. DD Form 1540, the registration form, shall be forwarded to the DTRA Contracting Officer for approval (DFARS 35.010(b)).

 

(End of clause)

 

252.227-9000 PROHIBITION OF USE OF LABORATORY ANIMALS (OCT 2008)(DTRA)

 

No animal studies may be conducted using DOD funds until Animal Care and Use Review Office (ACURO) approval has been granted. Studies involving non human primates, dogs, cats, or marine mammals will require a site visit by a DoD laboratory animal veterinarian. The recipient (including subcontractors) is expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the US Army Medical Research and Material Command (MRMC), Animal Care and Use Review Office (ACURO). You must complete the ACURO Animal Use Appendix for Research Involving Animals found at the following web site: https://mrmc-www.army.mil/AnimalAppendix.asp.

 

29

 

Please submit the completed ACURO appendix, contact information, the DTRA contract number and a copy of the contract for processing to the email address listed at the ACURO website for processing. You will receive written approval to begin research under the applicable protocol proposed for this award from the US Army MRMC ACURO under separate email to the recipient and Principal Investigator. A copy of this approval will be provided to the Defense Threat Reduction Agency (DTRA) for the official file. Non-compliance with any provision of this clause may result in the termination of the award.

 

(End of Clause)

 

252.235-9001 PROHIBITION OF USE OF LABORATORY ANIMALS (OCT 2008)(DTRA)

 

No animal studies may be conducted using DOD funds until Animal Care and Use Review Office (ACURO) approval has been granted. Studies involving non human primates, dogs, cats, or marine mammals will require a site visit by a DoD laboratory animal veterinarian. The recipient (including subcontractors) is expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the US Army Medical Research and Material Command (MRMC), Animal Care and Use Review Office (ACURO). You must complete the ACURO Animal Use Appendix for Research Involving Animals found at the following web site: https://mrmc-www.army.mil/AnimalAppendix.asp. Please submit the completed ACURO appendix, contact information, the DTRA contract number and a copy of the contract for processing to the email address listed at the ACURO website for processing. You will receive written approval to begin research under the applicable protocol proposed for this award from the US Army MRMC ACURO under separate email to the recipient and Principal Investigator. A copy of this approval will be provided to the Defense Threat Reduction Agency (DTRA) for the official file. Non-compliance with any provision of this clause may result in the termination of the award.

 

252.242-9000 CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) (NOV 2002)

 

1.  As required by FAR Parts 42 and 15, and DTRA policy for the Contractor Performance Assessment Reporting System (CPARS) and Past Performance Information Retrieval System (PPIRS), formerly known as PPAIS, effective July, 2001, the Government shall complete a CPAR each year of the period of performance of this contract. The contractor will have an opportunity to provide their comments in each CPAR before it is completed. In accordance with DTRA CPARS policy the completed CPARs will be entered into PPIRS, a retrieval system for Government source selection teams to access the CPARs of contractor’s performance. The DTRA CPARS and PPIRS policy includes an explanation of the process and procedures that will be utilized under this contract. A copy is available for contractor reference via the DTRAlink (www.dtra.mil) by accessing Acquisition, Doing Business With Us.

 

2.  The CPARs shall occur annually in accordance with the schedule established below:

 

(i)  Initial CPAR: 12 months after contract start date (date performance begins) TBD (by PCO)

 

(ii)  Interim CPAR(s) will be performed annually on the anniversary of the contract start date according to the following schedule: TBD (by PCO)

 

(iii)  A Final CPAR will be completed upon contract termination, transfer of program management/contract management responsibility outside of DTRA, the delivery of the final end item on contract and/or the completion of the performance period.

 

30

 

(iv)  An Out-of-Cycle CPAR may be required when there is a significant change in performance that alters the assessment in one or more evaluation area(s). An Out-of-Cycle CPAR is optional and shall be processed in accordance with DTRA CPARS policy referenced in paragraph 1. above.

 

3.  Each CPAR shall only cover the period elapsing from the last annual CPAR. The final CPAR shall not be used to summarize or “roll-up” the contractor’s performance under the entire contract. Each annual CPAR and the final CPAR together will comprise a total picture of contractor performance.

 

4.  At the request of the Government, a verbal, informal review of the Contractor’s performance may be held 3-6 months before the completion of the Interim or Final Evaluation periods. This review entails discussing any problems or areas of concern regarding the Contractor’s performance to date. No written evaluation form or other formal documentation is required for this evaluation. It may be conducted with the Contractor by telephone, teleconference or face-to-face. This is designed to offer the Contractor an opportunity to correct known deficiencies or weaknesses prior to the formal written evaluation.

 

5.  As set forth in DTRA CPARS policy, any disagreements between the Contractor and the Program Manager regarding the CPAR(s) that cannot be resolved shall be reviewed by the designated Reviewing Official prior to completion of the CPAR.

 

6.  Special Requirements for Indefinite Delivery Contracts (IDIQ and Requirements type), CPARs shall be processed (select one)

 

o for all existing orders (combined) at the time the CPAR is processed

 

o on an order-by-order basis

 

o on a grouped order basis

 

7.  The policy and procedures set forth in this clause and DTRA CPARS policy are not subject to “Disputes” as described in FAR Part 33.

 

252.245-9000 Government Property (AUG 2009)

 

(a)  In accordance with FAR 52.245-1(b), Property Management, and FAR 52.245-1(f), Contractor Plans and Systems, the Contractor shall have a system to manage (control, use, preserve, protect, repair and maintain) Government property in its possession.

 

(b)  The Contract Data Requirements Lists (CDRLs) associated with the Property for this Contract are contained in Exhibit “A” and included in Section J of this contract. The spreadsheet required by the CDRL entitled “Master Government Property List (MGPL) will be incorporated in Section J of this contract.

 

(c)  The Contractor shall provide to the Government an updated MGPL according to the CDRL.

 

(d)  The Government Site Visits/Physical Inventory — The DTRA will annually verify the Property in the Possession of the Contractor. The Contactor’s Point of Contact shall coordinate with the Program Manager/Contracting Officer Representative or DTRA Accountable Property Officer (APO) on prearranged site visits upon request.

 

(e)  The Contractor shall annually conduct and provide to the DTRA a physical inventory report of ALL Government Property in its possession according to the Master Government Property List (Physical Inventory) CDRL.

 

31

 

(f)  The physical inventory report shall be validated/confirmed via signature by both the Contractor’s Property Administrator and the DTRA’s Government Representative (i.e. COR, APO, etc.). Inventory discrepancies must be reported immediately to the Contracting Officer, COR/Program Manager and resolved by the DTRA APO.

 

(g)  The Contractor shall provide all CDRL reports to the Government electronically in a spreadsheet using Microsoft Office Excel. Unless otherwise specified, the contractor shall submit all data through the IUID Registry.

 

(End of Clause)

 

32

 

Section J - List of Documents, Exhibits and Other Attachments

 

Exhibit/Attachment Table of Contents

 

	
DOCUMENT TYPE
    	
 
    	
DESCRIPTION
    	
 
    	
PAGES
    	
 
    	
DATE
    
	
Exhibit A
    	
 
    	
CLIN 0002 Exhibit(s)
    	
 
    	
1
    	
 
    	
 
    
	
Attachment 1
    	
 
    	
Statement of Work
    	
 
    	
11
    	
 
    	
15-MAR-2009
    
	
Attachment 2
    	
 
    	
CDRLS
    	
 
    	
5
    	
 
    	
15-SEP-2009
    

 

33

 

Statement of Work

03/15/09

 

1.0  OBJECTIVE

 

Brief Overview of Specialty Area:  Our proposal addresses the topic: Protect the Department of Defense from WMD. We will attempt to develop new and improve existing antiviral vaccines to immunize the warfighter against often debilitating or lethal viral diseases. Our vaccine formulation will encode antigens from viral biothreat agents (e.g., Rift Valley fever virus (RVFV)) and will lead to a strong adaptive immune response against the targeted pathogens. These pre-treatments will also have utility for the general public in regions where the target pathogens are endemic or emerging, even in the United States where the spread of RVFV would rival that of West Nile virus.

 

Why Work is Being Pursued:  Viral infections present a significant threat to our troops abroad, to the United States mainland as a potential bioweapon, and to travelers and indigenous populations where the pathogens are endemic and/or emerging. Many viral agents are classified as NIAID Category A Priority Pathogens and as Biosafety Level (BSL-) 3 or 4 agents due to the lack of available vaccines and/or their case of dissemination by aerosol transmission. The initial focus will be to combine the broadly applicable aGal Adjuvant Technology with vaccine candidates against RVFV. This pathogen is a real and common threat. The lack of prophylactic and therapeutic measures, the potential for human-to-human transmission, and the significant threat to livestock associated with RVFV, make infection with these pathogens a serious public health concern not only in endemic, developing countries, but also in many non-endemic developed countries due to the recent bioterror threats. Until recently RVFV outbreaks had been limited to the African continent. However, the geographical range of RVFV has now expanded, with outbreaks in Saudi Arabia and Yemen in 2000 affecting both livestock and humans. More recent reports of infected livestock within Russia, Afghanistan and Northern India have been confirmed [77]. This is a clear indication that RVFV is not solely an African disease but a geographically rapidly expanding disease which is quickly becoming a threat to the US. Importantly, the number of outbreaks and lethality of these outbreaks have not lessened over time, and there are indications that they may have become more severe. The urgent need for an effective vaccine for RVFV is illustrated by the statistics from recent outbreaks: From 13th Jan to 3rd May 2007, a total of 264 cases including 109 deaths [case fatality ratio (CFR) 41%] of RVF were reported in Tanzania-; from 30th Nov 2006 to 12th Mar 2007, a total of 684 cases including 155 deaths (CFR 23%) of RVF were reported in Kenya. From 19th Dec 2006 to 20th Feb 2007, a total of 114 cases including 51 deaths (CFR 45%) of RVF were reported in Somalia [World Health Organization (WHO), CSR, Disease Outbreak News, Wed 9 May 2007]. Although the mortality rate for humans infected with RVFV previously reported was less than 2%, it is clear that the mortality rate in these recent outbreaks is substantially higher. Although not addressed by these reports, it is likely that morbidity is also substantially increased.

 

What We are Trying to Accomplish:  We will attempt to demonstrate the broad applicability of the aGal Adjuvant Technology to any existing or new antiviral vaccine platform to protect the warfighter from potentially lethal infection. These modified, 

 

 

improved vaccines against primarily viral pathogens identified as priority threats by the DoD will also be useful for the general population in areas where human pathogenic viral agents are endemic or emerging, as well as in the event of a suspected bioterror incident.

 

Overall, this proposed project will illustrate how the broad-spectrum aGal Adjuvant Technology will improve the efficacy of new and existing vaccines, which should lead to a reduction in the overall number of required vaccinations and a decrease of the vaccine dose, thus making vaccine production more cost-effective and for the end user (i.e., government: Strategic National Stockpile and National Veterinary Stockpile) more affordable.

 

2.0  SCOPE:  This proposal, “aGal Adjuvant Technology for Biodefense Agents”, is in support of the R&D Innovation Office (RD-INO).

 

Goals:  This effort will support the DTRA campaign, “Protect the Department of Defense from WMD”, aimed at developing Protection and Mitigation technologies, methodologies, and/or standards for eventual transition through the DTRA R&D Enterprise.

 

[*]

 

3.0  BACKGROUND

 

aGal Adjuvant Technology: Safety and Broad Applicability:  The purpose of an adjuvant is to stimulate the immune system to respond more strongly to an antigen than it normally would. A very good adjuvant can mean that a fraction of the antigen can be used to stimulate the body’s defense to create immunity to a disease. Since the antigen is the most expensive and difficult component required for the production of an effective vaccine, good adjuvants can be the key to generate any functional vaccine.

 

The aGal Adjuvant Technology exploits a robust zoonotic blockade against viruses from lower animals to enhance potency of antiviral vaccines. Human naturally acquired immunity against the common aGal epitope (galactose-alpha(1,3)-galactose-beta(1,4)N-acetyl-glucosamine-R (Gal-a(1-3 )-Gal-b(1.4)-GlcNAc-R) is facilitated by the loss of a key enzyme in the epitope’s biosynthetic pathway. Since human cells are devoid of this epitope, chronic stimulus from gut flora leads to high levels of circulating anti-aGal Abs (IgG and IgM) and the development of a robust immune response pathway. Because the aGal epitope is immediately recognized as foreign, the naturally acquired aGal immune pathway in humans serves as a strong barrier to zoonotic infection. The aGal Adjuvant Technology takes advantage of this natural process to facilitate the rapid presentation of modified antigens to antigen-presenting cells, leading to a strong immune response. The evolutionary immunity to aGal ensures that the presence of aGal epitopes on antigens will lead to a robust immune response involving cross-activation of TH1 immunity, characterized by cytokine secretion and increased phagocytic activity, and TH2 immunity characterized by high Abs titers. Interestingly, birds are also a1,3 GT-negative and this might explain why several pathogens transmitted by birds have readily jumped to humans (avian flu H5N1, West Nile virus, Eastern equine encephalitis).

 

 

Ab titers against aGal epitopes are among the highest recorded in humans and can comprise >2% of the entire circulating Ab repertoire. These Abs are also responsible for the well-documented immunologic phenomenon known as hyperacute rejection (of aGal(+) tissues), experimentally observed during attempts at xenotransplantation.

 

[*]

 

Product Management Plan:  The PI Dr. Link and the Program Manager Dr. Flick shall update the Product Development Plan within thirty (30) calendar days of the effective date of the contract. The contractor shall obtain approval of the Project Officer and Contracting Officer prior to the initiation of any activities related to its execution. Dr. Link shall oversee the performance of all activities based on the approved Implementation Plan. Both the PDP and Implementation Plan will be reviewed at a Post-Award Contract Initiation Meeting planned and coordinated by Dr. Link and shall include the PI, Project Manager, key investigators, and appropriate key contractor and subcontractor personnel, Project Officer, other DTRA and DoD staff designated by the Project Officer and the Contracting Officer. Dr. Flick and Dr. Link will provide oversight on the performance of all activities based on defined milestones and timelines approved by the Project Officer and the Contracting Officer. In addition, the PI and Program Manager will be responsible for the development of, review and recommendations for all proceed (Go/No Go) decision points throughout the period of performance, including listing quantitative and qualitative assessment criteria, both scientific and regulatory, for advancing the candidate vaccine past each Go/No Go decision point to the next stage of product development for all Research and Development Activities. In addition, they will be responsible for annual updates and any change in milestones. The contractor shall obtain approval of the Project Officer and the Contracting Officer of all updates and changes to the PDP prior to the initiation of any activities related to its execution. The contractor shall provide a detailed timeline, in Gantt chart format with predecessor and successor logic, covering the initiation, conduct and completion of each product development task that is linked to direct costs for each product development milestone identified in the PDP. Dr. Link will elicit input and recommendations as needed from all team member designees in developing the PDP, timelines, and management decisions. The PI shall submit all required reports (i.e., Quarterly Contract Performance Report, Cumulative Annual Progress Report, etc.) as defined in the Contract Data Requirement List (CDRL).

 

[*]

 

Procedures to handle adverse experimental or production developments:  The occurrence of adverse experimental data or production difficulties is fairly common in biologics development and manufacturing. The responsibility of every individual in the project is to address these problems in a constructive manner. Supervisory personnel, whether in the research laboratory or operating in QA/QC, will convey written notice of such problems or concerns to the project manager (or their designee) in a timely fashion. It is the responsibility of the project manager to convene a meeting of stakeholders in the affected processes to allow discussion of issues. These meetings 

 

 

will he recorded such that proposals that further define and/or resolve those problems are acted upon in a timely fashion. The Principal Investigator is responsible for determining whether satisfactory resolution has been achieved. If developments are such that the project goals are jeopardized or require actions outside the scope of the contract, the PI is required to assure notification of the Project Officer in a timely manner so that alternative strategies and/or remedial actions may be taken.

 

[*]

 

 

 

1

 

 

 

 

 

 

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