Based on 

Protocol _____ 

(TITLE) 

In Collaboration With 

(Pharmaceutical Company) 

DRAFT 

(Date) 

CLINICAL TRIAL COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT 

This agreement is made by and between the Centers for Disease Control and Prevention at 1600
Clifton Road, NE, Atlanta, Georgia 30333 ("CDC"), and , a corporation organized and existing
under the laws of the State of , having a place of business at ("Collaborator"). 

WHEREAS, ("Agent"), an investigational new drug or biological product, has demonstrated
promising results in preclinical testing and clinical trials; and 

WHEREAS, the Division of ("Division") of the center, institute or office ("CIO"),desires to enter
into a cooperative research and development agreement ("CRADA") with Collaborator, a
pharmaceutical firm with the facilities, experience and expertise necessary to develop Agent into an
approved drug or biological product available to the public; and 

WHEREAS, CIO,CDC and Collaborator (the "Parties") wish to collaborate on the clinical
development of Agent and to generate data necessary to obtain pharmaceutic regulatory approval
from the FDA and foreign counterparts of that agency to permit Collaborator to market Agent,
both in the United States and in foreign countries; and 

NOW THEREFORE, in consideration of the promises and undertakings described herein, the
Parties agree as follows: 

1 DEFINITIONS 

1.1 "Active Ingredient" means any component that is intended to furnish pharmacological activity
or other mitigation, treatment, or prevention of disease, or to affect the structure or any function of
the body of man or other animals. This term includes those components that may undergo chemical
change in the manufacture of the drug product and be present in the drug product in a modified form
intended to furnish the specified activity or effect, as defined in 21 C.F.R. 210.3(a)(7). 

1.2 "Annual Report" means an Annual Report which is a brief report of the progress of an
IND-associated investigation which the IND sponsor is required to submit to the FDA within 60
days of the anniversary date that the IND went into effect (pursuant to 21 C.F.R. õ 312.33).
According to CIO policy, Annual Reports pursuant to 21 C.F.R. õ 312.33 submitted for INDs
sponsored by the CIO are made available to the public upon written request. 

1.3 "Agent" means the drug or biological product defined above. 

1.4 "Confidential/Proprietary Information" means confidential scientific, business or financial data,
provided that such data: 

is not publicly known or available from other sources who are not under a confidentiality obligation
to the source of the information; 

has not been made available by its owners to others without a confidentiality obligation; 

is not already known by or available to the receiving Party without a confidentiality obligation; 

does not relate to potential hazards or cautionary warnings associated with the production, handling
or use of the subject matter of the Research Plan or Protocol of this CRADA; and 

does not include an Annual Report to the FDA. 

If any one or more of the above provisions of this definition is not met, the relevant data shall no
longer be considered proprietary data. 

1.5 "CRADA" or "Cooperative Research and Development Agreement" means this agreement,
entered into by CDC pursuant to the Federal Technology Transfer Act of 1986, as amended, and
Executive Order 12591 of October 10, 1987. 

1.6 "Designated Fields of Use" means the scope of research defined in the Research Plan. 

1.7 "DHHS" means the United States Department of Health and Human Services. 

1.8 "Drug Product" means a finished dosage form, for example, tablet, capsule, solution, etc.,that
contains Agent as an Active Ingredient generally, but not necessarily, in association with inactive
ingredients. The term also includes a finished dosage form that does not contain an Active
Ingredient but is intended to be used as a placebo, as defined in 21 C.F.R. 210.3(a)(4). 

1.9 "FDA" means the Food and Drug Administration, DHHS. 

1.10 "Government" means the government of the United States of America and any of its agencies. 

1.11 "Human Subjects" means individuals whose physiologic or behavioral characteristics and
responses are the object of study in a research project. Under the federal regulations for the
protection of human subjects, human subjects are defined as living individuals about whom an
investigator conducting research obtains: (1) data through intervention or interaction with the
individual;or (2) identifiable private information (45 C.F.R. 46.102(f)). 

1.12 "IND" means an Investigational New Drug Application. The IND is the legal mechanism under
which experimental drug research is performed in the United States. An IND is submitted to the
FDA to receive approval to conduct experimental clinical trials. The FDA regulations require
continual updates to the IND including, but not limited to, Annual Reports, adverse drug reaction
reports, new protocols, protocol amendments and pharmaceutical data. 

1.13 "NDA" means a New Drug Application. The NDA is the formal process by which the FDA
approves a drug for commercial distribution. 

1.14 "NIH" means the National Institutes of Health, PHS, DHHS. 

1.15 "Parties" means Collaborator and CDC. 

1.16 "PHS" means the Public Health Service, DHHS. 

1.17 "PLA" means a Product License Application. The PLA is the formal process by which the
FDA approves a biological for commercial distribution. 

1.18 "Protocol" means the protocol, number , which is entitled " ," and which is attached as
Appendix E. Appendix E is made a part of this CRADA as though fully set forth. Any statement in
the Protocol which is inconsistent with this CRADA is superseded by the CRADA. 

1.19 "Raw Data" means the primary quantitative and empirical data first collected by the
investigators from experiments and clinical trials conducted under the scope of this CRADA. 

1.20 "Research Plan" means the statement in Appendix B of the respective research and
development commitments of the Parties to this CRADA. 

1.21 "Research Results" means all tangible materials other than Subject Data first produced in the
performance of this CRADA. 

1.22 "Steering Committee" means a joint research and development team to conduct, evaluate,
and monitor the clinical trials in the Protocol in accordance with the Research Plan. 

1.23 "Subject Data" means all recorded information first produced in the performance of this
CRADA, including Raw Data and Summary Data. 

1.24 "Subject Invention" means any invention, conceived or reduced to practice in the performance
of research under this CRADA, that may be patentable under 35 U.S.C. 101 or 161,protectable
under 7 U.S.C. 2321, or otherwise protectable by other types of U.S. or foreign intellectual
property right. 

1.25 "Summary Data" means a summary of the Raw Data which will be made available to the
Division which summary is used by the Division to prepare an Annual Report to the FDA, said
Annual Report being available to the public in accordance with Division policy. 

2 STEERING COMMITTEE 

2.1 Promptly upon the execution of this CRADA, the Parties shall form a Steering Committee.
The Steering Committee will be responsible for the design, implementation, oversight and
evaluation of the preclinical and clinical research and development activities under this CRADA; for
determining the scope and magnitude of clinical trials necessary to explore Agent's clinical utility; for
establishing the order and priority of clinical efforts; and for other Agent preclinical and clinical
research and development activities to be conducted under this CRADA as otherwise agreed to by
the Steering Committee. 

2.2 The initial composition of the Steering Committee shall be three voting members on behalf of
CIO and three voting members on behalf of Collaborator. A Steering Committee member
representing either CIO or Collaborator will chair the Steering Committee. The membership of
the Steering Committee may be changed from time to time as mutually agreed by the Parties. 

2.3 Attendance at Steering Committee meetings shall be limited to members of the Steering
Committee and invited participants, as mutually agreed to by the Parties. 

2.4 The Steering Committee shall meet within one month of the execution of this CRADA, and
then regularly thereafter as appropriate. Minutes will be maintained at each meeting. 

2.5 The Steering Committee shall prepare, and the Parties shall approve and sign, written
summaries of each Steering Committee meeting. These summaries shall include information about
Steering Committee deliberations and describe issues addressed and decisions reached. Written
materials created by the Steering Committee shall be treated as described in Section 16. 

2.6 The Steering Committee will provide reports quarterly (or on an alternative schedule as
determined by the Steering Committee) to Parties on the progress of the various clinical trials
under their supervision and on research and development efforts subject to this CRADA. These
reports shall include all information included in INDs. 

2.7 At the first Steering Committee meeting, and at regular intervals thereafter, the Parties shall
provide to each other (1)information about the quantity of Agent available for clinical research and
other purposes pursuant to this CRADA agreed upon by the Steering Committee and within the
scope of the Research Plan and Protocol, together with relevant stability data; and (2) anticipated
time lines for drug production and supply for the activities subject to this CRADA. 

2.8 The Steering Committee shall prepare a final report of all results arising from all research
efforts and clinical trials as described in the Research Plan and Protocol, within four (4) months, or
on an alternative time schedule as determined by the Steering Committee, after completing the
projects or after the termination of this CRADA. 

2.9 In the event agreement cannot be reached by the Steering Committee on an issue subject to
this CRADA, the matter shall be referred to, and a decision will be made jointly by,
______________ (or such other individual as Collaborator may designate from time to time) of
Collaborator, and the Director of the Division, CIO. 

2.10 If the persons identified in Section 2.9 are unable to resolve a dispute within thirty (30) days
after referral from the Steering Committee, the Director of CIO shall propose a resolution in
writing. If Collaborator elects not to accept the resolution proposed by the Director of CIO, either
Party may terminate this CRADA or make a new proposal for resolution of the matter. 

3 STUDIES TO BE INITIATED PURSUANT TO THIS CRADA 

3.1 The Parties will collaborate on the design, oversight and implementation of the clinical studies
specified in the Research Plan and Protocol, with the objective of securing regulatory approval for
the commercialization of Agent. These studies will be selected and designed to be used by
Collaborator in an NDA or PLA to obtain pharmaceutic regulatory approval for the marketing of
Agent for the Designated Fields of Use. 

3.2 The Parties expect to collaborate on additional research and development of Agent, alone and
in conjunction with other agents, for indications other than the indications which are those set forth in
the Research Plan and Protocol. The Steering Committee shall be responsible for determining
the scope and magnitude of collaborative research for these additional indications. Such additional
studies and registrational plans for indications other than those set forth in the Research Plan and
Protocol may be added to this CRADA by amendment after approval by both the Steering
Committee and the Parties, and, if the Division considers the amendment to "significantly" modify
the scope of the research under this CRADA, after additional comment and approval by the CDC
CRADA approval process. 

3.3 It is understood that Collaborator or CIO shall be freeto sponsor additional research outside the
scope of this CRADA. Such research outside the scope of this CRADA includes studies of basic
mechanisms of Agent actions, derivatives, and analogues, and the use of Agent for other indications
not added by amendment to this CRADA. Collaborator or CIO may independently initiate clinical
trials involving Agent that are not set forth in the Research Plan or Protocol or added by
amendment pursuant to this Section, and any such trials are beyond the scope of this CRADA. 

4 FINANCIAL AND STAFFING CONTRIBUTIONS 

4.1 Collaborator shall provide the personnel, financial and other contributions set forth in Appendix
C. CIO shall provide the contributions including personnel, services and property, set forth in
Appendix C. CIO will provide no funding to Collaborator for collaborative research and
development pursuant to this CRADA, inasmuch as financial contributions by the Government to
nonFederal parties under a CRADA are not authorized under the Federal Technology Transfer Act
of 1986 (15 U.S.C. 3710(a)(b)(1)). 

4.2 CDC shall not be obligated to perform any of the research specified herein or take any other
action required by this CRADA if the funding is not provided as set forth in Appendix C. CDC shall
return excess funds, excluding staffing support in accordance with Section 18.8, to Collaborator
when it sends its final fiscal report pursuant to Section 4.3. 

4.3 CDC shall maintain separate and distinct current accounts, records, and other evidence
supporting all its obligations under this CRADA, and shall provide Collaborator an annual report
reflecting the use of Collaborator's funds and a final such fiscal report at the time that the final report
is prepared by the Steering Committee pursuant to Section 2.8. 

5 DRUG SUPPLY AND DISTRIBUTION 

5.1 At its own expense, Collaborator shall acquire and process all quantities of bulk Agent needed
to fulfill the formulated Drug Product requirements of this CRADA, as described in Section 2.7, as
feasible and appropriate. 

5.2 Collaborator, at its own expense, shall supply formulated Drug Product for all clinical trials set
forth in the Research Plan and Protocol, as such program may be amended from time to time by
the Steering Committee with the mutual written agreement of the Parties. Collaborator shall also
provide formulated Drug Product for CIO studies, described in the Research Plan. Drug Product
shall be shipped to repository or study sites as mutually agreed upon. 

5.3 Collaborator shall provide the CDC with the necessary Material Safety Data Sheet (MSDS) for
Drug Product together with any specific storage or shipping instructions. 

6INVESTIGATIONAL NEW DRUG APPLICATION SPONSORSHIP 

CDC shall be responsible for the submission of an IND covering Protocol. The IND shall satisfy all
of the requirements of the FDA. A letter granting cross reference to Collaborator's FDA files which
pertain to Agent shall be supplied by Collaborator, and, in return, CDC will also supply a letter, if
requested, granting cross reference to CDC'S IND to Collaborator. 

7 CLINICAL TRIAL SITES 

7.1 The CDC will utilize trial sites under Government Contract, Cooperative Agreement or other
arrangement set forth in the research Plan ("Clinical Trial Sites") for the studies described in the
Protocol. 

7.2 CDC will ensure that the Protocol will be conducted at Clinical Trial Sites according to the
FDA Good Clinical Practices Guidelines. 

7.3 Collaborator agrees to limit the conducting of the Protocol to CDC Clinical Trial Sites so
long as mutually agreed accrual targets are met. However, this commitment does not prohibit
Collaborator from conducting, at its own expense, additional clinical trials with Agent at nonCDC
sites. 

8 CASE REPORT FORM DEVELOPMENT 

The CDC shall assume responsibility for the development and subsequent revisions, if any, of Case
Report Forms with appropriate review and approval by the Steering Committee. 

9 REPORTING 

9.1 Adverse experience reports shall be collected by the CIO according to the procedures outlined
in the Protocol. 

9.2 The CIO shall assume total responsibility for the reporting of such adverse events to the FDA
with a copy to the Collaborator. 

9.3 The CIO shall report all serious and life threatening adverse events observed in this clinical trial
to Collaborator and Clinical Trial Sites on a timely basis consistent with Federal Regulations 21
C.F.R. 312.32. All other adverse experiences shall be reported by CIO to Collaborator on a timely
basis consistent with Federal Regulations 21 C.F.R. 312.33 for the Annual Report. Specific
provisions for reporting adverse experiences to agencies outside the U.S. shall be provided for as
required. 

9.4 Collaborator shall, in a timely manner and during the term of this trial, provide the CIO with any
information it now hasor may obtain in the future regarding the safety and/or the toxicity of Agent. 

10 DATA COLLECTION, MANAGEMENT, ANALYSIS AND REPORTING 

10.1 The CIO shall assume responsibility for the collection, management, analysis and initial
reporting of all data obtained from the trial. All Raw Data obtained from the trial shall be the
property of the Clinical Trial Site that produces the data. These data shall not be released to the
public except to the extent required by law. No persons or party other than Collaborator, its
contractor, and/or its designate shall have any rights to review and/or use the Raw Data obtained
from the trial for purposes of filing an NDA or PLA without the permission of Collaborator. 

10.2 Where applicable, the grouped data shall be controlled by the CIO and shall not be released to
the public without appropriate consultation with Collaborator. 

10.3 CIO agrees to maintain adequate and accurate records as required under 21 C.F.R. 312.62
relating to the disposition of the Drug Product and the treatment of Human Subjects under the
Protocol. 

10.4 CIO agrees to maintain the records required by 21 C.F.R. 312.62 for a minimum of two years
following the date a marketing application is approved for Agent for the indication which is being
investigated, or until two years after CIO has provided written notice to the Collaborator that the
investigation has been discontinued. 

10.5 Information which may be released to the public or which may have significant impact on
Collaborator's approval of Agent for commercial sale shall not be released without prior discussion
of the information with Collaborator except to the extent required by Federal Law. 

10.6 Collaborator retains the right to access and utilize the data and reports from this CRADA for
all legitimate business or regulatory purposes. Collaborator shall not at any time disclose the name
of any Human Subject or any information which identifies a Human Subject to a third party unless
specifically required to do so by law or the FDA. 

10.7 Collaborator, after appropriate consultation with the CIO, may provide information regarding
the trial to governmental organizations (e.g., FDA,Securities and Exchange Commission, etc.). 

10.8 Upon completion of the CRADA, Collaborator will be provided with a copy of the complete
analysis data set and other Raw Data as required in a machinereadable format to be determined
jointly. 

11 FDA MEETINGS 

One of the missions of the CIO is to ensure that active investigational therapies are approved and
made widely available in a timely fashion. Therefore, CIO feels it is important to participate in the
discussions with the FDA regarding regulatory matters covered in the Research Plan and Protocol.
CIO expects that Collaborator will actively pursue approval of Agent by the FDA and that
Collaborator will take the initiative in arranging formal meetings with the FDA. In addition,
Collaborator will have the option to set the agenda for such formal meetings. All formal meetings,
correspondence and discussions with FDA concerning any clinical trial conducted under this
CRADA, the data derived therefrom or any other matter concerning Agent will be discussed in
advance by the Parties. All formal meetings and discussions will be held on mutually agreed upon
dates. 

12 NEW DRUG APPLICATION OR PRODUCT LICENSE APPLICATION 

12.1 It is anticipated, and the Parties will utilize reasonable best efforts to see that an NDA or PLA
is to be filed in the name of Collaborator within four to six (46) years from the date of the execution
of this CRADA. 

12.2 Collaborator shall prepare and submit an NDA or PLA for Agent to the FDA and other
national pharmaceutic regulatory agencies as expeditiously as is feasible, when the Steering
Committee determines that such actions are justified by clinical results. However, should
Collaborator fail to prepare and submit an NDA or PLA to FDA within 18 months from the time
the Steering Committee determines that data are known to demonstrate reproducible activity that
would be sufficient to support an NDA or PLA, the CIO may terminate this CRADA under Section
18.5; but only if the failure to file an NDA or PLA by that date is established to be primarily due to
Collaborator's failure to exercise reasonable diligence in its pursuit of such NDA or PLA. In the
event the Steering Committee cannot reach a mutually agreeable, consensus agreement concerning
the provisions of this Section, then the dispute will be resolved according to the provisions of
Sections 2.9 and 2.10, and Section 25. Following said termination, CIO will be free to solicit
another collaborator. 

12.3 CIO shall cooperate with Collaborator as necessary and appropriate during the registration
process. 

13 COMMERCIALIZATION OF AGENT FOR THERAPY AND DIAGNOSIS 

13.1 CIO agrees to refrain from assisting any commercial party other than Collaborator in the
commercialization of Agent for the therapy and diagnosis of the conditions defined in Designated
Fields of Use during the terms of this CRADA, and shall use reasonable best efforts to assist
Collaborator in the commercialdevelopment of Agent for use in the Designated Fields of Use
during the term of this CRADA. 

13.2 After Agent becomes commercially available, Collaborator agrees to continue supplying
formulated Agent free of charge to investigators in the Division for clinical research protocols
conducted by CIO for _____ (_) years. 

13.3 To the extent permitted by law, and subject to appropriate confidentiality provisions of this
CRADA, CIO shall, during the term of this CRADA, provide to Collaborator all technical
information in CIO's possession that CIO deems appropriate to enable commercialization of Agent. 

14 COMPLIANCE WITH FEDERAL REGULATIONS 

14.1 Collaborator agrees to comply with all DHHS regulations relating to Human Subject use, all
U.S. Department of Agriculture regulations, and all PHS policies relating to the use and care of
laboratory animals. 

14.2 Informed consent of the Human Subjects participating in the clinical trials shall be obtained in
accordance with 21 C.F.R. Part 50 and Institutional Review Board ("IRB") review and approval of
the Protocol, including the Informed Consent form, shall be obtained in accordance with 21 C.F.R.
Part 56. The CIO agrees to supply Collaborator with evidence of IRB approval, a copy of the
Informed Consent form which is IRBapproved, and a copy of any modified Informed Consent form
later approved by the IRB and used. 

15 INTELLECTUAL PROPERTY RIGHTS, APPLICATIONS AND LICENSES 

15.1 The Parties shall promptly report to each other in writing each Subject Invention resulting
from the research conducted under this CRADA that is reported to them by their respective
employees. Such reports shall be treated in confidence by the receiving Party until such time as a
patent or other intellectual property (collectively "Intellectual Property") application, as
appropriate, claiming that Subject Invention has been filed. Because of the royalty sharing
provisions for Government inventors in the Federal Technology Transfer Act of 1986, and in view
of Section 15.12 which grants the Government only a research license on inventions made solely by
Collaborator, Collaborator acknowledges a special duty to report all Subject Inventions to CDC
so that CDC may determine whether or not inventorship properly includes CDC investigators. 

15.2 Collaborator may elect to retain Intellectual Property rights to any Subject Invention made
solely by a Collaborator employee. Collaborator shall notify CDC promptly upon making this
election. If Collaborator does not elect to retain its Intellectual Property rights, Collaborator shall
offer to assignthese Intellectual Property rights to the Subject Invention to CDC pursuant to
Section 15.5. If CDC declines such assignment, Collaborator may release its Intellectual Property
rights to employee inventors pursuant to Section 15.6. 

15.3 CDC on behalf of the Government may elect to retain Intellectual Property rights to each
Subject Invention made solely by CDC employees. If CDC does not elect to retain Intellectual
Property rights, CDC shall offer to assign these Intellectual Property rights to such Subject
Invention to Collaborator pursuant to Section 15.5. If Collaborator declines such assignment,
CDC may release Intellectual Property rights in such Subject Invention to its employee inventors
pursuant to Section 15.6. 

15.4 Each Subject Invention made jointly by CDC and Collaborator employees shall be jointly
owned by CDC and Collaborator. Collaborator may elect to file the joint Intellectual Property
application(s) thereon and shall notify CDC promptly upon making this election. If Collaborator
decides to file such applications, it shall do so in a timely manner and at its own expense. If
Collaborator does not elect to file such application(s), CDC on behalf of the Government shall
have the right to file the joint application in a timely manner and at its own expense. If either Party
decides not to retain its Intellectual Property rights to a jointly owned Subject Invention, it shall
offer to assign such rights to the other Party pursuant to Section 15.5. If the other Party declines
such assignment, the offering Party may release its Intellectual Property rights to employee
inventors pursuant to Section 15.6. 

15.5 With respect to Subject Inventions made by Collaborator as described in Section 15.2 or by
CDC as described in Section 15.3, a Party exercising its right to elect to retain its Intellectual
Property rights to a Subject Invention agrees to file Intellectual Property applications in a timely
manner and at its own expense. The Party may elect not to file an Intellectual Property application
thereon in any particular country or countries provided it so advises the other Party ninety (90) days
prior to the expiration of any applicable filing deadline, priority period or statutory bar date, and
hereby agrees to assign its Intellectual Property right, title and interest in such country or countries
to the Subject Invention to the other Party and to cooperate in the preparation and filing of an
Intellectual Property applications. In any countries in which title to Intellectual Property rights is
transferred to Collaborator, Collaborator agrees that CDC inventors will share in any royalty
distribution that Collaborator pays its own inventors. 

15.6 In the event neither of the Parties to this CRADA elects to file an Intellectual Property
application on a Subject Invention, either or both (if a joint invention) may release their
Intellectual Property rights to their respective employeeinventor(s) with a nonexclusive,
nontransferrable, royaltyfree license being retained by each Party. 

15.7 The expenses attendant to the filing of Intellectual Property applications generally shall be
paid by the Party filing such application. If an exclusive license to any Subject Invention is granted
to Collaborator, Collaborator shall pay CIO for the reasonable past and Collaboratorapproved
ongoing funds expended worldwide for filing, prosecuting and maintaining any applications claiming
such exclusivelylicensed inventions and any Intellectual Property grants that may issue on such
applications. Such payment shall constitute a part of Collaborator's contribution to this CRADA.
Collaborator may waive its exclusive license rights on any application, patent or other Intellectual
Property grant at any time, and incur no subsequent compensation obligation for that application,
patent or Intellectual Property grant. 

15.8 Each Party shall provide the other Party with copies of the applications it files on any Subject
Invention along with the power to inspect and make copies of all documents retained in the
Intellectual Property application files by the applicable patent or other Intellectual Property
office. The Parties agree to consult with each other with respect to the prosecution of CDC Subject
Inventions described in Section 15.3 and joint Subject Inventions described in Section 15.4. If
Collaborator elects to file and prosecute Intellectual Property applications on joint Subject
Inventions pursuant to Section 15.4, CDC will be granted an associate power of attorney (or its
equivalent) on such Intellectual Property applications. 

15.9 With respect to Government Intellectual Property rights to any Subject Invention not
made solely by Collaborator's employees for which an Intellectual Property application is filed,
CDC hereby grants to Collaborator an option to negotiate, in good faith, the terms of an exclusive
or nonexclusive commercialization license for the Designated Fields of Use that fairly reflect the
relative contributions of the Parties to the invention and the CRADA, the risks incurred by
Collaborator and the costs of subsequent research and development needed to bring the invention
to the marketplace. The terms of the license shall be consistent with the policy set forth in Appendix
A and will specify the licensed fields of use, breadth of exclusivity and royalties. Royalty rates will be
based on product sales and the rates conventionally granted in the field identified in the license for
inventions with reasonably similar commercial potential. Royalty rates generally will not exceed a rate
within the range of five to eight percent (58%) for exclusive commercialization licenses. Contingent
royalty schemes based on, e.g., patent issuance or nonissuance, and provisions treating the stacking
of royalties or packaging of other licensed inventions developed under this CRADA may be
provided. Exclusive licensees will be expected to pay CIO for Intellectual Property expenses
related to each licensedintellectual property, and such payment shall constitute a part of
Collaborator's contribution to this CRADA. 

15.10 The option of Section 15.9 must be exercised by written notice mailed within three (3) months
after the Intellectual Property application is filed to the CDC Technology Transfer Office, 1600
Clifton Road, NE, Mailstop E-67, Atlanta, GA 30333. Exercise of this option by Collaborator
initiates a negotiation period that expires nine (9) months after the Intellectual Property application
filing date. If the last proposal by Collaborator has not been responded to in writing by CDC within
this nine (9) month period, the negotiation period shall be extended to expire one (1) month after
CDC so responds, during which month Collaborator may accept in writing the final license proposal
of CDC. After that time, CDC will be free to license such Intellectual Property rights to others. 

15.11 CDC has a concern that there be a reasonable relationship between the pricing of a licensed
product, the public investment in that product, and the health and safety needs of the public.
Accordingly, exclusive commercialization licenses granted for CDC intellectual property rights may
require that this relationship be supported by reasonable evidence. 

15.12 For inventions developed wholly by CDC investigators or jointly with a Collaborator under
this CRADA, CDC is required by the Federal Technology Transfer Act of 1986, 15 U.S.C. at
3710a(b)(2), to retain at least a nonexclusive, irrevocable, paidup license to practice the invention or
to have the invention practiced throughout the world by or on behalf of the Government. For
inventions developed wholly by Collaborator under this CRADA, Collaborator agrees to grant a
research license to the Government. 

15.13 CDC reserves the right under any Intellectual Property license granted to Collaborator
under this CRADA to grant nonexclusive licenses to third parties to make and to use the licensed
invention for purposes of research involving the invention itself, and not for purposes of commercial
manufacture or in lieu of purchase as a commercial product for use in other research. CDC intends
to consult with its exclusive commercialization licensee(s) before granting research licenses to
commercial entities. 

15.14 In the event that Collaborator does not acquire an exclusive commercialization license to
Intellectual Property rights in joint Subject Inventions described in Section 15.4, then each Party
shall have the right to use the joint Subject Invention and to license its use to others. The Parties
may agree to a joint licensing approach for such Intellectual Property rights. 

16 CONFIDENTIAL/PROPRIETARY INFORMATION 

16.1 To the extent permitted by law and subject to the termsof confidentiality set forth in this Section
and the right of publication afforded by Section 17 of this CRADA, the Parties agree that any
information or documents created or exchanged pertaining to the Raw Data, Research Plan or
Protocol of this CRADA, including all discussions and information exchanged at meetings of the
Steering Committee, and in written summaries of Steering Committee meetings shall be
maintained confidential to the Parties, and shall not be disclosed to any third parties without
consultation with the Steering Committee. 

16.2 When a summary of Raw Data generated by a clinical study is made available to the Division
and this Summary Data is used by the Division to prepare an Annual Report to the FDA, this said
Division Annual Report prepared from said Summary Data is not confidential and is available to
the public in accordance with Division policy. 

16.3 CIO shall make all Raw Data resulting from the research and development efforts of this
CRADA in its control or possession available exclusively to Collaborator for use in obtaining
pharmaceutic regulatory approval for the commercial marketing of Agent throughout the world. CIO
shall require in all contracts with contract investigators for Agent clinical trials and in all CIO clinical
research that the Raw Data shall be so used and maintained, and no contract for Agent clinical trials
research under this CRADA shall be executed absent such investigator's concurrence regarding
confidentiality and such exclusive use by Collaborator for obtaining commercialization rights for
Agent. With respect to extramural research grants, CIO shall urge extramural investigators to
cooperate exclusively with Collaborator in providing Raw Data for use in obtaining pharmaceutic
regulatory approval for the commercial marketing of Agent. However, CIO's urging is not intended
to constitute a term or condition for making a grant award to said extramural investigators. 

16.4 The following statement is included in all Contracts through which Division funds clinical trials:
"In accordance with HHSAR 352.22470, Confidentiality of Information (APR 1984), which is
incorporated by reference in this contract, the Contractor shall ensure the confidentiality of the
following data or information which may be made available to the contractor in the course of work to
be performed hereunder: 1) proprietary information contained in INDs and reports to the FDA
containing such data; 2) proprietary data in CIO databases; 3) confidential information in all Adverse
Drug Reaction ("ADR") documentation; 4) all information regarding clinical trials protocols in the
preapproval stage; and 5) any protocol related proprietary data. Any dissemination of data relating
to these documents and information shall be cleared through the Contracting Officer for the purpose
of identifying any inadvertent disclosure of the data or information prior to any oral or written release
of information. This includes abstracts and preprints and materials to be presented at conferences or
in publicforums. All proprietary and/or confidential data will be so marked, except in the case of
protocols which shall be totally confidential in the preapproval stage." 

16.5 CDC agrees that all written information marked "Confidential" and received from
Collaborator, and received by and agreed to by CDC which is Confidential/Proprietary
Information is the sole and exclusive property of Collaborator during the period of this CRADA
and subsequent thereto. Likewise, all information which is disclosed visually or orally by
Collaborator and subsequently confirmed as Confidential Information in writing within ten (10)
working days after first disclosure will be held as Confidential/Proprietary Information. 

16.6 CDC agrees not to disclose Collaborator's Confidential/Proprietary Information to any
person, except CIO investigator(s), Clinical Trial Site investigators, members of the IRB or, as
required, to the FDA, without the prior written consent of Collaborator and further agrees to take
all reasonable precautions to prevent the disclosure by the CIO investigator(s), Clinical Trial Site
investigators, and the IRB of Collaborator's Confidential/Proprietary Information to a third
party. 

16.7 The CDC agrees to use Collaborator's Confidential/Proprietary Information only in the
conduct of the CRADA and evaluation of its results, and not for its own purposes. 

16.8 While the CDC will endeavor to control the distribution of the Protocol document itself,
Collaborator acknowledges that a list of all protocols which are open to patient enrollment are
available (with abstracts) to the public under the Freedom of Information Act. 

16.9 The obligation to maintain confidentiality of information shall expire at the earlier of the date
when the information is no longer Confidential/Proprietary Information or three (3) years after the
expiration or termination date of this CRADA. Collaborator may request an extension to this term
when necessary to protect Confidential/Proprietary Information relating to products not yet
commercialized. 

17 PUBLICATION 

17.1 Subject to the obligations of the Parties to maintain the Raw Data generated under this
CRADA as confidential and proprietary, the Parties may publicly disclose the results of their
research under the circumstances set forth in this Section. 

17.2 Before either Party submits a paper or abstract for publication of information subject to this
CRADA, the other Party shall be provided thirty (30) days to review the proposedpublication to
assure that confidential and proprietary data is protected. The publication shall be delayed for up to
thirty (30) additional days upon written request by either Party as necessary to preserve U.S. or
foreign patent or other intellectual property rights. Nothing contained in Section 16.1 of this CRADA
shall prevent the timely publication of the results of clinical trials conducted under this CRADA. 

17.3 Except as to the obligations of contract investigators to maintain Raw Data as confidential and
proprietary to Collaborator for use in obtaining pharmaceutic regulatory approval for the
commercial marketing of Agent as described in Section 16.3 of this CRADA, nothing contained
herein shall restrict the rights of extramural investigators to publish the results of their research in
accordance with applicable policies of CDC. 

17.4 Any publications based on the results of the trial shall conform to the applicable CDC
publication policy. Recognizing that Collaborator scientists may play an important role in the design,
analysis, and interpretation of the findings of the trial, consideration shall be given by the Principal
Scientists at the Clinical Trial Sites under Government Contract or Cooperative Agreement and
CDC to include appropriate individuals from Collaborator in the authorship of publications based
on the trial. 

18 TERM AND TERMINATION 

18.1 The effective date of this CRADA with respect to all provisions is the date of the last signature
to this CRADA. 

18.2 This CRADA shall expire on the earlier to occur of completion of the Research Plan or
__________________. 

18.3 This CRADA may be terminated at any time by mutual consent of the Parties. 

18.4 Either Party may unilaterally terminate this CRADA at any time by giving written notice to the
other Party at least sixty (60) days prior to the desired termination date. 

18.5 Either Party may terminate this CRADA if the other Party breaches a material term or
condition, and if the breach is not cured within a period of sixty (60) days after written notice of
breach is given to the other Party. 

18.6 Either Party may, under the circumstances set forth in Sections 2.10 and Section 18.5,
terminate this CRADA or make a new proposal for the resolution of the matter if Collaborator
declines to accept the recommended resolution of the Director of CIO concerning a matter covered
by said Sections. 

18.7 On expiration or earlier termination of this CRADA, thedisposition of the Subject Data,
property, studies and Drug Product shall be determined by the Steering Committee, and all Drug
Product to be transferred to CIO upon expiration or earlier termination of this CRADA shall be
provided at cost by Collaborator. 

18.8 If this CRADA is mutually or unilaterally terminated prior to its expiration, funds will
nevertheless remain available to CDC for continuing any staffing commitment made by Collaborator
pursuant to Appendix C, if applicable, for a period of six (6) months after such termination. If there
are insufficient funds to cover this expense, Collaborator agrees to pay the difference. 

19 ENTIRE AGREEMENT AND AMENDMENTS 

19.1 This CRADA constitutes the entire agreement between the Parties concerning the subject
matter of this CRADA and supersedes any prior understanding or written or oral agreement,
including those related agreements designated in Appendix D or related documents. 

19.2 If either Party desires a modification to this CRADA, the Parties shall, upon reasonable notice
of the proposed modification or extension by the Party desiring the change, confer in good faith to
determine the desirability of such modification or extension. Such modification shall not be effective
until a written amendment is signed by the signatories to this CRADA or by their representatives duly
authorized to execute such amendment. 

19.3 Appendices A through E are attached to this CRADA, and incorporated herein by reference.

20 NOTICES 

20.1 All notices pertaining to or required by this CRADA shall be in writing and shall be signed by
an authorized representative and shall be delivered by hand or sent by certified mail, return receipt
requested, with postage prepaid, to the addresses indicated on the signature page for each Party.
Any notices in writing and payments to be made under this CRADA will be deemed duly given and
made if sent by courier or by certified or registered mail, postage prepaid. Communications between
the Parties will be addressed to the following persons, or to such other persons as the Parties may
designate from time to time in writing: 

For CIO,CDC: 

Director, Division of _______________ 
Centers for Disease Control and Prevention 
MailStop ____ 
1600 Clifton Road, N.E. 
Atlanta, Georgia 30333 

For Collaborator: 

______________________ 

________________ _____ 

____________________ __ 

_______________________ 

20.2 Any Party may change such address by notice given to the other Party in the manner set forth
above. 

20.3 Notices regarding the exercise of license options shall be made pursuant to Section 15.10. 

21 WAIVERS 

None of the provisions of this CRADA shall be considered waived by any Party unless such waiver
is given in writing to the other Party. The failure of a Party to insist upon strict performance of any of
the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law,
shall not be deemed a waiver of any rights of any Party. The waiver by either Party of a breach of
any provisions of this CRADA will not operate or be construed as a waiver of any subsequent
breach. 

22 GOVERNING LAW 

The construction, validity, performance and effect of this CRADA shall be governed by Federal law,
as applied by the Federal Courts in the District of Columbia. Fen