DARPA Flowdown

Attachment to Purchase Order Terms and Conditions (U.S. and Puerto Rico Only)

(“Attachment”)

U.S. Department of Defense – Defense Advanced Research Programs Agency (DARPA)

Required Flow-Down Terms

The clauses set forth in this Attachment to this Purchase Order, together with the Pfizer Purchase Order Terms and Conditions, are hereby incorporated with full force and effect and are applicable to the performance of this Purchase Order by Supplier (hereinafter referred to as “SUPPLIER” for purposes of this Attachment).

As used in this Attachment the following capitalized terms shall have the following meanings:

DARPA shall mean The Defense Advanced Research Project Agency, an agency of the U.S. Department of Defense.

DARPA Funding Agreement shall mean that certain Technology Investment Agreement by and between Pfizer Inc. and The Defense Advanced Research Projects Agency, effective as of December 9, 2013.

Government shall mean the United States of America, as represented by DARPA.

Government or DARPA Agreements Officer and Government or DARPA Agreements Officer Representative shall mean:

MICHAEL S. MUTTY
DARPA Agreements Officer
DARPA/CMO (HR0011)
675 N. Randolph Street
Arlington, VA 20105
Phone: 571-218-4588
Email: [email protected]

DR. MICHELINE STRAND
Agreement Officer’s Representative (AOR)
U.S. Army Research Office (W911NF)
4300 South Miami Blvd.
Durham, NC 27709-2211
Phone: 919-549-4343
Email: [email protected]

SUPPLIER shall, at the request of Pfizer, accept modifications to this Attachment to incorporate additional clauses and provisions herein, or to change clauses and provisions hereof, as Pfizer may reasonably deem necessary in order to comply with the clauses and provisions of the DARPA Funding Agreement, or with the clauses and provisions of modifications to such DARPA Funding Agreement. If any such modification to this Purchase Order causes an increase or decrease in the price of, or the time required for, performance by SUPPLIER of any part of its obligations under this Purchase Order, SUPPLIER may submit a request for an equitable adjustment, and the parties shall, in good faith, negotiation an appropriate equitable adjustment, if any, as the parties mutually agree.

I. ACCESS TO RECORDS: In addition and as a supplement to all rights, actions and obligations set forth in Section 4, AUDIT, of the Pfizer Purchase Order Terms and Conditions, the Comptroller General of the United States, in its discretion, shall have access to and the right to examine SUPPLIER’s records that directly pertain to, and involve transactions relating to, this Purchase Order for a period of three (3) years after final payment is made is made to Pfizer under the DARPA Funding Agreement. This requirement shall not apply with respect to any party to this Purchase Order or any entity that participates in the performance of the Purchase Order, or any subordinate element of such party or entity, that, in the year prior to the date of the Purchase Order, has not entered into any other contract, grant, cooperative agreement, or “other transaction” agreement that provides for audit access to its records by a government entity in the year prior to the date of this Purchase Order. This paragraph only applies to any record that is created or maintained in the ordinary course of business or pursuant to a provision of law. The terms of this paragraph shall be included in all sub-agreements/contracts that SUPPLIER may enter into under this Purchase Order.

II. PATENT RIGHTS:

A. Definitions

1. “Invention” means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code.

2. “Made” when used in relation to any invention means the conception or first actual reduction to practice of such invention.

3. “Practical Application” means to manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is capable of being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

4. “Subject Invention” means any invention conceived or first actually reduced to practice in the performance of work under this Purchase Order.

5. “License” or “license” with respect to SUPPLIER and of its subcontractors means the right to make, have made, use, have used, lease, offer for sale, sell and/or otherwise transfer any machine, article of manufacture or composition of matter and to practice or have practiced any process.

B. Allocation of Principal Rights

Unless SUPPLIER shall have notified DARPA (in accordance with subparagraph C.2 below) that SUPPLIER does not intend to retain title and if, and to the extent, consistent with Section 11 of the Pfizer Purchase Order Terms and Conditions, SUPPLIER shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article and 35 U.S.C. § 202 and 203. With respect to any Subject Invention in which SUPPLIER retains title, DARPA shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States, for Government Purposes, the Subject Invention throughout the world.

C. Invention Disclosure, Election of Title, and Filing of Patent Application

1. SUPPLIER shall disclose each Subject Invention to DARPA within six (6) months after the inventor discloses it in writing to his/her company personnel responsible for patent matters. The disclosure to DARPA shall be in the form of a written report and shall identify the Purchase Order under which the invention was made and the identity of the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the invention. The disclosure shall also identify any publication, sale, or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure. SUPPLIER shall also submit to DARPA an annual listing of Subject Inventions.

2. Within eight (8) months of disclosure of each Subject Invention, SUPPLIER shall elect whether to retain title to such Subject Invention and shall notify DARPA in writing of such election. However, in any case where publication, sale, or public use has initiated the one (1)-year statutory period wherein valid patent protection can still be obtained in the United States, SUPPLIER shall make such election and shall give written notice to DARPA not less than sixty (60) calendar days prior to the end of the statutory period.

3. SUPPLIER shall file its initial patent application on a subject invention to which it elects to retain title within one (1) year after election of title or, if earlier, prior to the end of the statutory period wherein valid patent protection can be obtained in the United States after a publication, or sale, or public use. SUPPLIER may elect to file patent applications in additional countries (including the European Patent Office and the Patent Cooperation Treaty) within either ten (10) months of the corresponding initial patent application or six (6) months from the date permission is granted by the Commissioner of Patents and Trademarks to file foreign patent applications, where such filing has been prohibited by a Secrecy Order.

4. Requests for extension of the time for disclosure, election, and filing under this paragraph, may, at the discretion of DARPA, and after considering the position of SUPPLIER, be granted.

5. All required Subject Invention and patent-related reporting shall be accomplished, to the extent possible, using the i-Edison reporting website https://s-edison.info.nih.gov/iEdison/. SUPPLIER shall provide to Pfizer, and Pfizer shall upload Form DD 882 for subject invention certifications and subcontractor identification in connection with Pfizer’s annual reporting, whenever possible. To the extent any such reporting cannot be carried out by use of i -Edison, reports and communications shall be submitted to the DARPA Agreements Officer and Administrative Agreements Officer.

D. Conditions When the Government May Obtain Title

Upon DARPA’s written request, SUPPLIER shall convey title to any Subject Invention to DARPA under any of the following conditions:

1. If SUPPLIER fails to disclose or elects not to retain title to the Subject Invention within the times specified in paragraph C of this Article; provided, that DARPA may only request title within sixty (60) calendar days after learning of the failure of SUPPLIER to disclose or elect within the specified times.

2. In those countries in which SUPPLIER fails to file patent applications within the times specified in paragraph C of this Article; provided, that if SUPPLIER has filed a patent application in a country after the times specified in paragraph C of this Article, but prior to its receipt of the written request by DARPA, alternatively if SUPPLIER files a patent application in the foreign country within sixty (60) days of receipt of the written request by DARPA, SUPPLIER shall continue to retain title in that country; or

3. In any country in which SUPPLIER decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceedings on, a patent on a Subject Invention.

E. Minimum Rights to SUPPLIER and Protection of SUPPLIER’s Right to File

1. SUPPLIER shall retain a nonexclusive, royalty-free license throughout the world in each Subject Invention to which the Government obtains title, except if Pfizer fails to disclose the invention within the times specified in paragraph C of this Article. The SUPPLIER license extends to all subsidiaries and affiliates, if any, within the corporate structure of which SUPPLIER is a party and includes the right to grant licenses of the same scope to the extent permitted under U.S. Law and regulations. The license is transferable only with the approval of DARPA, approval for license transfer shall not be unreasonably withheld.

2. The foregoing SUPPLIER license may be revoked or modified as to a specific Government Purpose use by the Government to the extent necessary to achieve expeditious practical application of the Subject Invention pursuant to an application for an exclusive license submitted consistent with appropriate provisions at 37 CFR Part 404. SUPPLIER shall retain a nonexclusive, non-transferrable (other than to a successor) license in all fields of use other than the specific Government Purpose use that DARPA revokes or modifies. Further, this license shall not be revoked in that field of use or the geographical areas in which SUPPLIER has achieved practical application and continues to make the benefits of the invention reasonably accessible to the public. The license in any foreign country may be revoked or modified at the discretion of DARPA to the extent SUPPLIER, its licensees, or the subsidiaries or affiliates have failed to achieve practical application in that foreign country.

3. Before revocation or modification of the license, DARPA shall furnish SUPPLIER a written notice of its intention to revoke or modify the license, and SUPPLIER shall be allowed thirty (30) calendar days (or such other time as may be authorized by DARPA for good cause shown) after the notice to show cause why the license should not be revoked or modified.

F. Action to Protect the Government’s Interest

1. SUPPLIER agrees to execute or to have executed and promptly deliver to DARPA all instruments necessary to (i) establish or confirm the rights the Government has throughout the world in those Subject Inventions to which SUPPLIER elects to retain title, and (ii) convey title to DARPA when requested under paragraph D of this Article and enable the Government to obtain patent protection throughout the world in that subject invention.

2. SUPPLIER agrees to require, by written agreement, its employees, other than clerical and non-technical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by SUPPLIER each Subject Invention made under this Purchase Order, so that SUPPLIER can comply with the disclosure provisions of paragraph C of this Article. SUPPLIER shall instruct employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U. S. or foreign statutory bars and to preserve the Government’s Interest in the Subject Invention.

3. SUPPLIER shall promptly notify DARPA of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceedings on a patent, in any country, not less than thirty (30) calendar days before the expiration of the response period required by the relevant patent office.

4. SUPPLIER shall include, within the specification of any United States patent application and any patent issuing thereon covering a Subject Invention, the following statement:

“This invention was made with Government support under Agreement No. HR0011-14-3-0001 awarded by DARPA. The Government has certain rights in the invention.”

G. Lower Tier Agreements

SUPPLIER shall include this Article, suitably modified to identify the parties, in all subcontracts or lower tier agreements, regardless of tier, for experimental, developmental, or research work. SUPPLIER shall ensure that the rights granted to the Government herein are also enforceable against all subcontractors and lower tiers. SUPPLIER agrees that DARPA may enforce its rights under this Patent Rights clause directly against SUPPLIER or through Pfizer.

H. Reporting on Utilization of Subject Inventions

1. SUPPLIER agrees to submit, during the term of the Purchase Order, an annual report on the utilization of all Subject Invention and on efforts at obtaining such utilization that is being made by SUPPLIER or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by SUPPLIER, and such other data and information as the agency may reasonably specify. SUPPLIER also agrees to provide additional reports as may be requested by DARPA in connection with any march-in proceedings undertaken by DARPA in accordance with paragraph J of this Article. Consistent with 35 U.S.C. § 202(c) (5), DARPA agrees it shall not disclose such information to persons outside the Government without permission of SUPPLIER.

2. All required reporting shall be accomplished, to the extent possible, Pfizer using the i- Edison reporting website https://s-edison.info.nih.gov/iEdison/. To the extent any such reporting cannot be carried out by use of iEdison, reports and communications shall be submitted to the Agreements Officer and Administrative Agreements Officer.

I. Preference for American Industry

Notwithstanding any other provision of this clause, SUPPLIER agrees that it shall not grant to any person other than SUPPLIER Affiliates the exclusive right to use or sell any Subject Invention in the United States or Canada unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention shall be manufactured substantially in the United States or Canada. However, in individual cases, the requirements for such an agreement may be waived by DARPA upon a showing by SUPPLIER that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that, under the circumstances, domestic manufacture is not commercially feasible.

J. March-in Rights

SUPPLIER agrees that, with respect to any Subject Invention in which it has retained title, DARPA has the right to require SUPPLIER, an assignee, or exclusive licensee of a Subject Invention to grant a non-exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if SUPPLIER, assignee, or exclusive licensee refuses such a request, DARPA has the right to grant such a license itself if DARPA determines that:

1. Such action is necessary because SUPPLIER or assignee has not taken effective steps, consistent with the intent of this Purchase Order, to achieve practical application of the Subject Invention;

2. Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by SUPPLIER, assignee, or their licensees;

3. Such action is necessary to meet requirements for public use and such requirements are not reasonably satisfied by SUPPLIER, assignee, or licensees; or

4. Such action is necessary because the agreement required by paragraph (I) of this Article has not been obtained or waived or because a licensee of the exclusive right to use or sell any Subject Invention in the United States is in breach of such agreement. SUPPLIER and DARPA agree that the procedures set forth at 37 CFR 401.6 shall govern the exercise of march-in-rights.

III. DATA RIGHTS:

A. Definitions

1. “Government Purpose Rights”, as used in this Article and elsewhere in the Purchase Order, means rights to use, modify, reproduce, release, perform, display, or disclose Data, in whole or in part and in any manner, for Government purposes only, and to have or permit others to do so for Government purposes only.

2. “Government Purpose,” as used in this Article and elsewhere in the Purchase Order, 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 Data for commercial purposes or authorize others to do so.

3. “Unlimited Rights”, as used in this Article, means rights to use, modify, reproduce, release, perform, display, or disclose Data, in whole or in part, in any manner and for any purposes whatsoever, and to have or permit others to do so.

4. “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 or management information.

5. “Computer Software” as used in this Article, means computer programs, source and object/compiled 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 software documentation.

6. “Computer Software Documentation” as used in this Article, 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 computer software.

7. “Data”, as used in this Article, means recorded information, regardless of form or method of recording, including, but not limited to, Technical Data (to include computer software documentation), Computer Software, trade secrets, and mask works. The term does not include financial, administrative, cost, pricing or management information and does not include Subject Inventions.

8. “Background Technical Data” means any Technical Data that was not produced, generated or delivered under a previously executed Government Contract, Grant, Cooperative Agreement or Other Transaction Agreement.

9. “Foreground Technical Data” means Technical Data produced, generated, or delivered in the performance of work under this Purchase Order.

10. “Limited Rights”, as used in this Article, 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 Technical 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 Technical 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.

11. “Restricted Rights”, as used in this Article, means the Government’s rights to:

(i) Use a computer program with one computer at one time. The program may not be accessed by more than one terminal or central processing unit or time shared unless otherwise permitted by this Purchase Order;

(ii) Transfer a computer program to another Government agency without the further permission of the Contractor if the transferor destroys all copies of the program and related computer software documentation in its possession and notifies the licensor of the transfer. Transferred programs remain subject to the provisions of this Article;

(iii) Make the minimum number of copies of the computer software required for safekeeping (archive), backup, or modification purposes;

(iv) Modify computer software, provided that the Government may –

(A) Use the modified software only as provided in paragraphs A (10) (i) and (iii) of this Article; and

(B) Not release or disclose the modified software except as provided in paragraphs (A) (10) (ii) of this Article.

12. “Practical Application” means to manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the related Subject Invention or Inventions is or are capable of being utilized and that its or their benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

B. Allocation of Principal Rights

1. This Purchase Order may be performed with mixed Government and Contractor (i.e., Pfizer) funding. Except as provided in B (4) and B (5) below, if mixed Government and Contractor funding is used, the Government shall receive Government Purpose Rights, in perpetuity, in all Data developed, generated, or delivered under this Purchase Order.

2. SUPPLIER agrees to retain and maintain in good condition until one (1) year after expiration or termination of the DARPA Funding Agreement, all Data necessary to achieve practical application. In the event of exercise of the Government’s March-in Rights as set forth under Article II or subparagraph B.3 of this article, SUPPLIER agrees, upon written request from the Government, to deliver at no additional cost to the Government, all Data necessary to achieve practical application within sixty (60) calendar days from the date of the written request. The Government shall retain Unlimited Rights, as defined in paragraph A above, to this delivered Data.

3. SUPPLIER agrees that, with respect to Data to achieve Practical Application of Subject Inventions, DARPA has the right to require SUPPLIER to deliver all such Data to DARPA in accordance with its reasonable directions if DARPA determines that:

a. Such action is necessary because SUPPLIER or assignee has not taken effective steps, consistent with the intent of the DARPA Funding Agreement and this Purchase Order, to achieve Practical Application within sixty (60) calendar days from the date of the written request of the technology developed during the performance of this Purchase Order;

b. Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by SUPPLIER, assignee, or their licensees; or

c. Such action is necessary to meet requirements for public use and such requirements are not reasonably satisfied by SUPPLIER, assignee, or licensees.

4. With respect to all Data delivered, in the event of the Government’s exercise of its right under subparagraph B (2) of this Article, the Government shall receive Unlimited Rights as defined in paragraph A above.

5. With respect to any Data delivered which has been developed or generated at private expense, not including Data generated at private expense as part of the Pfizer’s cost share under the DARPA Funding Agreement, the Government shall receive Limited/Restricted Rights.

C. Marking of Data

Pursuant to paragraph B above, any Data delivered under this Purchase Order shall be marked with the following legend:

Use, duplication, or disclosure is subject to the restrictions as stated in Agreement HR0011-14-3-0001 between the Government and Pfizer.

D. Lower Tier Agreements

SUPPLIER shall include this Article, suitably modified to identify the parties, in all subcontracts or lower tier agreements, regardless of tier, for experimental, developmental, or research work. SUPPLIER shall ensure that the rights granted to the Government herein are also enforceable against all subcontractors and lower tiers. SUPPLIER further agrees that this Article III, Data Rights, may be enforced directly against SUPPLIER by the United States Government.

IV. FOREIGN ACCESS TO TECHNOLOGY:

This Article shall remain in effect for all Purchase Orders issued during the term of the DARPA Funding Agreement and for three (3) years thereafter.

A. Definition

1. “Foreign Firm or Institution” means a firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Purchase Order, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals. For purposes of this Purchase Order, including but not limited to this Article IV, this definition of “Foreign Firm or Institution” does not include any affiliate or subsidiary of Pfizer where permitted under U.S. Law and regulations.

2. “Know-How” means all information including, but not limited to discoveries, formulas, materials, inventions, processes, ideas, approaches, concepts, techniques, methods, software, programs, documentation, procedures, firmware, hardware, technical data, specifications, devices, apparatus and machines.

3. “Technology” means discoveries, innovations, Know-How and inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, maskworks, and copyrights developed under this Purchase Order.

4. “Affiliates or “affiliates”, as used throughout this Purchase Order, means, with respect to Pfizer, the legal entities that (directly or indirectly) control, are controlled by, or are under common control with Pfizer. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of at least 50% of the voting securities or other ownership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity.

B. General

The parties agree that research findings and technology developments arising under both the DARPA Funding Agreement and this Purchase Order may constitute a significant enhancement to the national defense, and to the economic vitality of the United States. Accordingly, access to important technology developments under this Purchase Order by Foreign Firms or Institutions must be carefully controlled. The controls contemplated in this Article are in addition to, and are not intended to change or supersede, the provisions of the International Traffic in Arms Regulation (22 CFR pt. 121 et seq.), the DoD Industrial Security Regulation (DoD 5220.22-R) and the Department of Commerce Export Regulation (15 CFR pt. 770 et seq.)

C. Restrictions on Sale or Transfer of Technology to Foreign Firms or Institutions

1. In order to promote the national security interests of the United States and to effectuate the policies that underlie the regulations cited above, the procedures stated in subparagraphs C.2, C.3, and C.4 below shall apply to any transfer of Technology. For purposes of this paragraph, a transfer includes a sale of the company, and sales or licensing of Technology. Transfers do not include:

(a) sales of products or components, or

(b) licenses of software or documentation related to sales of products or components, or

(d) transfer which provides access to Technology to a Foreign Firm or Institution which is an approved source of supply or source for the conduct of research under this Purchase Order provided that such transfer shall be limited to that necessary to allow the firm or institution to perform its approved role under this Purchase Order.

2. SUPPLIER shall provide timely notice to Pfizer and DARPA of any proposed transfers from SUPPLIER of Technology developed under the DARPA Funding Agreement or this Purchase Order to Foreign Firms or Institutions. If DARPA determines that the transfer may have adverse consequences to the national security interests of the United States, Pfizer, SUPPLIER, its vendors, and DARPA shall jointly endeavor to find alternatives to the proposed transfer which obviate or mitigate potential adverse consequences of the transfer but which provide substantially equivalent benefits to SUPPLIER.

3. In any event, SUPPLIER shall provide written notice to Pfizer and the DARPA Agreements Officer’s Representative and Agreements Officer of any proposed transfer to a Foreign Firm or Institution at least sixty (60) calendar days prior to the proposed date of transfer. Such notice shall cite this Article and shall state specifically what is to be transferred and the general terms of the transfer. Within thirty (30) calendar days of receipt of Pfizer’s written notification, the DARPA Agreements Officer shall advise SUPPLIER whether it consents to the proposed transfer. In cases where DARPA does not concur or sixty (60) calendar days after receipt and DARPA provides no decision, SUPPLIER may request that Pfizer, on behalf of SUPPLIER and at SUPPLIER’s expense, utilize the procedures under the DARPA Funding Agreement Article VI, Disputes. No transfer shall take place until a decision is rendered.

4. In the event a transfer of Technology to Foreign Firms or Institutions which is NOT approved by DARPA takes place, SUPPLIER shall (a) refund to DARPA funds paid for the development of the Technology and (b) the Government shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States the Technology throughout the world for Government and any and all other purposes, particularly to effectuate the intent of the DARPA Funding Agreement and this Purchase Order. Upon request of Pfizer and/or the Government, SUPPLIER shall provide written confirmation of such licenses.

D. Lower Tier Agreements

SUPPLIER shall include this Article, suitably modified to identify the parties, in all subcontracts or lower tier agreements, regardless of tier, for experimental, developmental, or research work. SUPPLIER shall ensure that the rights granted to the Government herein are also enforceable against all subcontractors and lower tiers. SUPPLIER agrees that the United States Government may enforce this Article directly against SUPPLIER.

V. CIVIL RIGHTS ACT:

This Purchase Order is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. 2000-d) relating to non-discrimination in Federally assisted programs. SUPPLIER represents and warrants that it is in compliance with, and shall comply with, the nondiscriminatory provisions of the Act.

VI. EXPORT CONTROL

(a) Definition. “Export-controlled items,” as used in this clause, means items subject to the Export Administration Regulations (EAR) (15 CFR Parts 730-774) or the International Traffic in Arms Regulations (ITAR) (22 CFR Parts 120-130). The term includes:

1) “Defense items,” defined in the Arms Export Control Act, 22 U.S.C. 2778(j)(4)(A), as defense articles, defense services, and related technical data, and further defined in the ITAR, 22 CFR Part 120.

2) “Items,” defined in the EAR as “commodities”, “software”, and “technology,” terms that are also defined in the EAR, 15 CFR 772.1.

(b) SUPPLIER shall comply with all applicable laws and regulations regarding export controlled items, including, but not limited to, the requirement for SUPPLIER to register with the Department of State in accordance with the ITAR. SUPPLIER shall consult with the Department of State regarding any questions relating to compliance with the ITAR and shall consult with the Department of Commerce regarding any questions relating to compliance with the EAR.

(c) SUPPLIER’s responsibility to comply with all applicable laws and regulations regarding export-controlled items exists independent of, and is not established or limited by, the information provided by this clause.

(d) Nothing in the terms of this Purchase Order adds, changes, supersedes, or waives any of the requirements of applicable Federal laws, Executive orders, and regulations, including but not limited to—

(1) The Export Administration Act of 1979, as amended (50 U.S.C. App. 2401, et seq.);

(2) The Arms Export Control Act (22 U.S.C. 2751, et seq.);

(3) The International Emergency Economic Powers Act (50 U.S.C. 1701, et seq.);

(4) The Export Administration Regulations (15 CFR Parts 730-774);

(5) The International Traffic in Arms Regulations (22 CFR Parts 120-130);

And,

(6) Executive Order 13222, as extended;

(e) SUPPLIER shall include the substance of this clause, including this paragraph (e), in all subcontracts.

VII: ANIMAL STUDIES [This Clause shall only apply if the SUPPLIER’s efforts under this Purchase Order both (1) includes work supporting the DARPA Funding Agreement; and (2) includes research that involves the use of animals].

Research that involves the use of animals shall be administratively reviewed by a U.S. Department of Defense (DoD) veterinarian prior to the SUPPLIER initiating any animal research. The SUPPLIER is not to begin any research or purchase any materials, equipment, etc that would involve animal use until the protocol has been approved.

Once the SUPPLIER receives its copy of the Protocol Approval Letter from DoD Regulatory Office, the SUPPLIER is approved to proceed with the effort involving animal use, in accordance with guidance in the Protocol Approval Letter. DARPA Contracts Management Office will incorporate the Protocol Approval Letter as an attachment to the contract.

VIII: ANIMAL WELFARE [This Clause shall only apply if the SUPPLIER’s efforts under this Purchase Order both (1) includes work supporting the DARPA Funding Agreement; and (2) includes research that involves the use of animals].

(a) The SUPPLIER shall register its research facility with the Secretary of Agriculture in accordance with 7 U.S.C. 2316 and 9 CFR Subpart C, and Section 2.30, and furnish evidence of such registration to the Contracting Officer before beginning work under this agreement.

(b) The SUPPLIER shall acquire animals only from dealers licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Subpart A, Sections 2.1 through 2.11, or from sources that are exempt from licensing under those sections.

(c) The SUPPLIER agrees that the care and use of animals will conform with the pertinent laws of the United States and regulations of the Department of Agriculture (see 7 U.S.C. 2131 et. seq. and 9 CFR Subchapter A, Parts 1 through 4).

(d) Pfizer may immediately suspend, in whole or in part, work and further payments under this Purchase Order for failure to comply with the requirements of paragraphs (a) through (c) of this clause.

(1) The suspension will stay in effect until the SUPPLIER complies with the requirements.

(2) Failure to complete corrective action within the time specified by Pfizer or the Government Agreements Officer may result in termination of this agreement and removal of the SUPPLIER's name from the list of contractors with approved Public Health Service Welfare Assurances.

(e) The SUPPLIER may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA), for the region in which its research facility is located. The location of the appropriate APHIS regional office, as well as information concerning this program may be obtained by contacting the Senior Staff Officer, Animal Care Staff, USDA/APHIS, Federal Center Building, Hyattsville, MD 20782.

(f) The SUPPLIER shall include this clause, including this paragraph (f), in all subcontracts involving research of live vertebrate animals.