**Exhibit 10.40**

**Cooperative Research and Development Agreement**

** **

**(CACR - 0774)**

** **

**Clinical Development of Perifosine**

****

**Sherry Ansher, Ph.D.Janet Dancey, M.D.CTEPDCTD**

** **

**Dr. rer. nat.****RainerVoegeli**

**ASTA Medica, Inc.**

** **

**Prepared byTechnology Development and CommercializationBranchNational Cancer Institute**

****

 

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PUBLIC HEALTH SERVICE

**COOPERATIVE RESEARCH AND DEVELOPMENTAGREEMENT**

** **

This Cooperative Research and Development Agreement,hereinafter referred to as the “CRADA,” consists of this Cover Page, and attached Agreement, and various Appendicesreferred in the Agreement.  This Cover Page serves to identify the Parties to this CRADA:

                                              (1)                the following Bureau(s),Institute(s), Center(s) or Division(s) of the National Institutes of Health (“NIH”), the Food and Drug Administration(“FDA”), and the Centers for Disease Control and Prevention (“CDC”):

National Cancer Institute, hereinafter singly or collectively referred to asthe Public Health Service (“PHS”); and

                                              (2)                ASTA Medica, Incorporated, which hasoffices at 890 East Street, Tewksbury, MA  01876, hereinafter referred to as the “Collaborator.”

 

 

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**COOPERATIVE RESEARCH AND DEVELOPMENTAGREEMENT**

## **Article 1.  Introduction**

This Cooperative Research and Development Agreement (CRADA) between PHS andthe Collaborator will be effective when signed by all Parties.  The research and development activities which will beundertaken by each of the Parties in the course of this CRADA are detailed in the Research Plan (RP) which is attached as AppendixA.  The funding and staffing commitments of the Parties are set forth in Appendix B.  Any exceptions or changes to theCRADA are set forth in Appendix C.  This CRADA is made under the authority of the Federal Technology Transfer Act, 15 U.S.C.§3710a and is governed by its terms.

## **Article 2.  Definitions**

As used in this CRADA, the following terms shall have the indicatedmeanings:

| 2.1    | **“Affiliate”** means any corporation or other business entity    controlled by, controlling, or under common control with Collaborator.     For this purpose, A “control” means direct or indirect beneficial ownership    of at least fifty (50) percent of the voting stock or at least fifty (50)    percent interest in the income of such corporation or other business. |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.2    | **“Cooperative Research and Development Agreement”** or “CRADA” means    this Agreement, entered into by PHS pursuant to the Federal Technology    Transfer Act of 1986, as amended, 15 U.S.C. 3710a etseq. and    Executive Order 12591 of October 10, 1987.                                                                                                                       |
| 2.3    | **“Government”** means the Government of the United States as represented    through the PHS agency that is a Party to this agreement.                                                                                                                                                                                                                                                        |
| 2.4    | **“IP”** means intellectual property.                                                                                                                                                                                                                                                                                                                                                         |
| 2.5    | **“Invention”** means any invention or discovery which is or may be    patentable or otherwise protected under title 35, United States Code, or any    novel variety or plant which is or may be protectable under the Plant    Variety Protection Act (7 U.S.C. 2321 etseq.).                                                                                                                |
| 2.6    | **“Principal Investigator(s)”** or **“PIs”** means the persons    designated respectively by the Parties to this CRADA who will be responsible    for the scientific and technical conduct of the RP.                                                                                                                                                                               |
| 2.7    | **“Proprietary/Confidential Information”** means confidential scientific,    business, or financial information provided that such information does not    include:                                                                                                                                                                                                                           |
|   | 2.7.1                                                                                                                                                                                                                                                                                                                                                                                                   | information that is publicly known or available from other sources who are    not under a confidentiality obligation to the source of the information; |
|   | 2.7.2                                                                                                                                                                                                                                                                                                                                                                                              | information which has been made available by its owners to others without a    confidentiality obligation; |
|   | 2.7.3                                                                                                                                                                                                                                                                                                                                                                                                   | information which is already known by or available to the receiving Party    without a confidentiality obligation; or |
|   | 2.7.4                                                                                                                                                                                                                                                                                                                                                                                                   | information which relates to potential hazards or cautionary warnings    associated with the production, handling or use of the subject matter of the    Research Plan of this CRADA. |
| 2.8    | **“ResearchMaterials”** means all tangible materials other than Subject Data first produced in the performance of thisCRADA.                                                                                                                                                                                                                                                                |

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| 2.9                                                     | **“ResearchPlan”** or **“RP”** means the statement in Appendix A of the respective research and development commitmentsof the Parties to this CRADA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.10                                                    | **“SubjectInvention”** means any Invention of the Parties, conceived or first actually reduced to practice in the performance of theResearch Plan of this CRADA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| 2.11                                                    | **“SubjectData”** means all recorded information first produced in the performance of this CRADA by the Parties.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| **Article 3.  Cooperative Research**               |
| 3.1                                                     | **PrincipalInvestigators.**  PHS research work under this CRADA will be performed by the PHS laboratory identified in the RP, and thePHS Principal Investigator (PI) designated in the RP will be responsible for the scientific and technical conduct of this projecton behalf of PHS.  Also designated in the RP is the Collaborator PI who will be responsible for the scientific and technicalconduct of this project on behalf of the Collaborator.                                                                                                                                                                                                                                                                                                                                                                        |
| 3.2                                                     | **Research PlanChange.**  The RP may be modified by mutual written consent of the Principal Investigators.  Substantial changes in thescope of the RP will be treated as amendments under Article 13.6.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
| **Article 4.  Reports**                            |
| 4.1                                                     | **InterimReports. ** The Parties shall exchange formal written interim progress report on a schedule agreed to by the PIs, but atleast within twelve (12) months after this CRADA becomes effective and at least within every twelve (12) months thereafter. Such reports shall set forth the technical progress made, identifying such problems as may have been encountered and establishinggoals and objectives requiring further effort, any modifications to the Research Plan pursuant to Article 3.2, and allCRADA-related patent applications filed.                                                                                                                                                                                                                                                                    |
| 4.2                                                     | **FinalReports.**  The Parties shall exchange final reports of their results within four (4) months after completing the projectdescribed in the RP or after the expiration or termination of this CRADA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| **Article 5.  Financial and Staffing Obligations** |
| 5.1                                                     | **PHS andCollaborator Contributions.**  The contributions of the Parties, including payment schedules, if applicable, are set forthin Appendix B.  PHS shall not be obligated to perform any of the research specified herein or to take any other actionrequired by this CRADA if the funding is not provided as set forth in Appendix B.  PHS shall return excess funds to theCollaborator when it sends its final fiscal report pursuant to Article 5.2, except for staffing support pursuant to Article10.3  Collaborator acknowledges that the U.S. Government will have the authority to retain and expend any excess funds for upto one (1) year subsequent to the expiration or termination of the CRADA to cover any costs incurred during the term of the CRADAin undertaking the work set forth in the RP. |
| 5.2                                                     | **AccountingRecords.**  PHS shall maintain separate and distinct current accounts, records, and other evidence supporting all itsobligations under this CRADA, and shall provide the Collaborator a final fiscal report pursuant to Article 4.2.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 5.3                                                     | **CapitalEquipment.**  Equipment purchased by PHS with funds provided by the Collaborator shall be the property of PHS.  Allcapital equipment provided under this CRADA by one party for the use of another Party remains the property of the providing Partyunless other disposition is mutually agreed upon by in writing by the Parties.  If title to this equipment remains with theproviding Party, that Party is responsible for maintenance of the equipment and the costs of its transportation to and from thesite where it will be used.                                                                                                                                                                                                                                                                         |

 

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| **Article 6.  Intellectual Property Rights and PatentApplications** |
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| 6.1                                                                      | **Reporting.**  TheParties shall promptly report to each other in writing each Subject Invention resulting from the research conducted under thisCRADA that is reported to them by their respective employees.  Each Party shall report all Subject Inventions to the otherParty is sufficient detail to determine inventorship.  Such reports shall be treated as Proprietary/Confidential Informationin accordance with Article 8.4. |
| 6.2                                                                      | **Collaborator EmployeeInventions.**  If the Collaborator does not elect to retain its IP rights, the Collaborator shall offer to assign these IPrights to the Subject Invention to PHS pursuant to Article 6.5.  If PHS declines such assignment, the Collaborator may releaseits IP rights as it may determine. |
| 6.3                                                                      | **PHSEmployee Inventions. ** PHS on behalf of the U.S. Government may elect to retain IP rights to each Subject Invention madesolely by PHS employees.  If PHS does not elect to retain IP rights, PHS shall offer to assign these IP rights to such SubjectInvention to the Collaborator pursuant to Article 6.5.  If the Collaborator declines such assignment, PHS may release IPrights in such Subject Invention to its employee inventors pursuant to Article 6.6. |
| 6.4                                                                      | **JointInventions.**  Each Subject Invention made jointly by PHS and Collaborator employees shall be jointly owned by PHS andCollaborator.  The Collaborator may elect to file the joint patent or other IP application(s) thereon and shall notify PHSpromptly upon making this election.  If the Collaborator decides to file such applications, it shall do so in a timely mannerand at its own expense.  If the Collaborator does not elect to file such application(s), PHS on behalf of the U.S. Governmentshall have the right to file the joint application(s) in a timely manner and at its own expense.  If either Party decides notto retain its IP rights to a jointly owned Subject Invention, it shall offer to assign such rights to the other Party pursuant toArticle 6.5.  If the other Party declines such assignment, the offering Party may release its IP rights as provided inArticles 6.2, 6.3 and 6.6. |
| 6.5                                                                      | **Filing ofPatent Applications.**  With respect to Subject Inventions made by the Collaborator as described in Article 6.2, or by PHSas described in Article 6.3, a Party exercising its right to elect to retain IP rights to a Subject Invention agrees to file patentor other IP applications in a timely manner and at its own expense and after consultation with the other Party.  The Partyshall notify the other Party of its decision regarding filing in countries other than the United States in a timely manner. The Party may elect not to file a patent or other IP application thereon in any particular country or countries provided it soadvises the other Party ninety (90) days prior to the expiration of any applicable filing deadline, priority period or statutorybar date, and hereby agrees to assign its IP right, title and interest in such country or countries to the Subject Invention to theother Party and to cooperate in the preparation and filing of a patent or other IP applications.  In any countries in whichtitle to patent or other IP rights is transferred to the Collaborator, the Collaborator agrees that PHS inventors will share in anyroyalty distribution that the Collaborator pays to its own inventors. |
| 6.6                                                                      | **Releaseto Inventors.**  In the event neither of the Parties to this CRADA elects to files a patent or other IP application on aSubject Invention, either or both (if a joint invention) may retain or release their IP rights in accordance with their respectivepolicies and procedures.  However, the Government shall retain a nonexclusive, non-transferable, irrevocable, royalty-freelicense to practice any such Subject Invention or have it practiced throughout the world by or on behalf of theGovernment. |
| 6.7                                                                      | **PatentExpenses.**  The expenses attendant to the filing of patent or other IP applications generally shall be paid by the Partyfiling such application.  If an exclusive license to any Subject Invention is granted to the Collaborator, the Collaboratorshall be responsible for all past and future out-of-pocket expenses in connection with the preparation, filing, prosecution andmaintenance of any applications claiming such exclusively-licensed inventions and any patents or other IP grants that may issue onsuch applications.  The Collaborator may waive its exclusive license rights on any application, patent or other IP grant atany time, and incur no subsequent compensation obligation for that application, patent or IP grant. |
| 6.8                                                                      | **Prosecution of IntellectualProperty Applications. ** Within one month of receipt or filing, each Party shall provide the other Party with copies of theapplications and all documents received from or filed with the relevant patent or other IP office in connection with theprosecution of such applications.  Each Party shall also provide the other Party with the power to inspect and make copies ofall documents retained in the patent or other IP application files by the applicable patent or other IP office.  Wherelicensing is contemplated by Collaborator, the Parties agree to consult with each other with respect to the prosecution ofapplications for PHS Subject Inventions described in Article 6.3 and joint Subject Inventions described in Article 6.4  If theCollaborator elects to file and prosecute IP applications on joint Subject Inventions pursuant to Article 6.4, PHS will be grantedan associate power of attorney (or its equivalent) on such IP applications. |

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| **Article 7.  Licensing** |
|--------------------------------|
| 7.1                            | **Optionsfor Commercialization License.**  With respect to Government IP rights to any Subject Invention not made sole by theCollaborator’s employees for which a patent or other IP application is filed, PHS hereby grants to the Collaborator an*exclusive* option to elect an exclusive or nonexclusive commercialization license, which s substantially in the form of theappropriate model PHS license agreement.  This option does not apply to Subject Inventions conceived prior to the effectivedate of this CRADA that are reduced to practice under this CRADA, if prior to that reduction to practice, PHS has filed a patentapplication on the invention and has licensed it or offered to license it to a third party.  The terms of the license willfairy reflect the nature of the invention, the relative contributions of the Parties to the invention and the CRADA, the risksincurred by the Collaborator and the costs of subsequent research and development needed to bring the invention to themarketplace.  The field of use of the license will be commensurate with the scope of the RP. |
| 7.2                            | **Exerciseof License Option.**  The option of Article 7.1 must be exercised by written notice mailed within three (3) months aftereither (i) Collaborator receives written notice from PHS that the patent or other IP application has been filed; or (ii) the dateCollaborator files such IP application.  Exercise of this option by the Collaborator initiates a negotiation period thatexpires none (9) months after the exercise of the option.  If the last proposal by the Collaborator has not been responded toin writing by PHS within this nine (9) month period, the negotiation period shall be extended to expire one (1) month after PHS soresponds, during which month the Collaborator may accept in writing the final license proposals of PHS.  In the absence ofsuch acceptance, or an extension of the time limits by PHS, PHS will be free to license such IP rights to others.   In theevent that the Collaborator elects the option for an exclusive license, but not such license is executed during the negotiationperiod.  PHS agrees not to make an offer for an exclusive license on more favorable terms to a third party for a period of sic(6) months without first offering Collaborator those more favorable terms.  These times may be extended at the sole discretionof PHS upon good cause shown in writing by the Collaborator. |
| 7.3                            | **Licensefor PHS Employee Inventions and Joint Inventions.**  Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for Subject Inventionsmade under this CRADA by a PHS employee(s) or jointly by such employee(s) and employees of the Collaborator pursuant to Articles6.3 and 6.4 and licensed pursuant to the option of Article 7.1, the Collaborator grants to the Government a nonexclusive,nontransferable, irrevocable paid-up license to practice the invention or have the invention practiced throughout the world by oron behalf of the Government.  In the exercise of such license the Government shall not publicly disclose trade secrets orcommercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. 552(b)(4) or which would beconsidered as such if it had been obtained from a non-Federal party. |
| 7.4                            | **Licensein Collaborator Inventions.**  Pursuant to 15 U.S.C. § 3710a(b)(2), for inventions made solely by Collaboratoremployees under this CRADA pursuant to Article 6.2, the Collaborator grants to the Government a nonexclusive, nontransferable,irrevocable, paid-license to practice the invention or have the invention practiced throughout the world by or on behalf of theGovernment for research or other Government purposes. |
| 7.5                            | **ThirdParty License.**  Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive license to a Subject Inventionmade wholly by PHS employees or jointly with a Collaborator under this CRADA, pursuant to Articles 6.3 and 6.4, the Governmentshall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, orexclusive sublicense to use the invention in Collaborator’s licensed field of use on terms that are reasonable under thecircumstances; or if the Collaborator fails to grant such a license, to grant the license itself.  The exercise of such rightsby the Government shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary tomeet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirementsfor public use specified by Federal regulations, and such requirements are not reasonably satisfied by the Collaborator, or (iii)the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. 3710a(c)(4)(B).  Thedetermination made by the Government under this Article is subject to administrative appeal and judicial (review under 35 U.S.C.203(2). |

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| 7.6                                                     | **JointInventions Not Exclusively Licensed. ** In the event that the Collaborator does not acquire an exclusive commercializationlicense to IP rights in all fields in joint Subject Inventions described in Article 6.4, then each Party shall have the right touse the joint Subject Invention and to license its use to others in all fields not exclusively licensed to Collaborator.  TheParties may agree to a joint licensing approach for such IP rights.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
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| **Article 8.  Proprietary Rights and Publication** |
| 8.1                                                     | **Right ofAccess.**  PHS and the Collaborator agree to exchange all Subject Data produced in the course of research under thisCRADA.  Research Materials will be shared equally by the Parties to the CRADA unless other disposition is agreed to by theParties.  All Parties to this CRADA will be free to utilize Subject Data and Research Materials for their own purposes,consistent with their obligations under this CRADA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
| 8.2                                                     | **Ownership of Subject Dataand Research Materials.**  Subject to the sharing requirements of Paragraph 8.1 and the regulatory filing requirements ofParagraph 8.3, the producing Party will retain ownership of and title to all Subject Inventions, all Subject Data and all ResearchMaterials produced solely by their investigators.  Jointly developed Subject Inventions, Subject Data and Research Materialswill be jointly owned.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
| 8.3                                                     | **Dissemination of SubjectData and Research Materials.**  To the extent permitted by law, the Collaborator and PHS agree to use reasonable efforts tokeep Subject Data and Research Materials confidential until published  or until corresponding patent applications arefiled.  Any information that would identify human subjects of research or patients will always be maintainedconfidentially.  To the extent permitted by law, the Collaborator shall have the exclusive right to use any and all CRADASubject Data in and for any regulatory filing by or on behalf of Collaborator, except that PHS shall have the exclusive right touse Subject Data for that purpose, and authorize others to do so, if the CRADA is terminated or if Collaborator abandons itscommercialization efforts.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 8.4                                                     | **Proprietary/ConfidentialInformation.**  Each Party agrees to limit its disclosure of Proprietary/Confidential Information to the amount necessary to carry outthe Research Plan of this CRADA, and shall place a confidentiality notice on all such information.  Confidential oralcommunications shall be reduced to writing within 30 days by the disclosing Party.  Each Party receivingProprietary/Confidential Information agrees that any information so designated shall be used by it only for the purpose describedin the attached Research Plan.  Any Party may object to the designation of information as Proprietary/Confidential Informationby another Party.  Subject Data and Research Materials developed solely by the Collaborator may be designated asProprietary/Confidential Information when they are wholly separate from the Subject Data and Research Materials developed jointlywith PHS investigators, and advance designation of such data and material categories is set forth in the RP.  The exchange ofother confidential information, e.g., patient-identifying data, should be similarly limited and treated.  Jointly developedSubject Data and Research Material derived from the Research Plan may be disclosed by Collaborator to a third party under aconfidentiality agreement for the purpose of possible sublicensing pursuant to the Licensing Agreement and subject to Article8.7. |
| 8.5                                                     | **Protection ofProprietary/Confidential Information. ** Proprietary/Confidential Information shall not be disclosed, copied, reproduced orotherwise made available to any other person or entity without the consent of the owning Party except as required under court orderor the Freedom of Information Act (5 U.S.C. 552).  Each Party agrees to use its best efforts to maintain the confidentialityof Proprietary/Confidential Information.  Each Party agrees that the other Party is not liable for the disclosure ofProprietary/Confidential Information which, after notice to and consultation with the concerned Party, the other Party ispossession of the Proprietary/Confidential Information determines may not be lawfully withheld, provided the concerned Party hasbeen given an opportunity to seek a court order to enjoin disclosure.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |

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| 8.6                                                 | **Duration of ConfidentialityObligation.**  The obligation to maintain the confidentiality of Proprietary/Confidential Information shall expire at theearlier of the date when the information is no longer Proprietary Information as defined in Article 2.7 or three (3) years afterthe expiration or termination date of this CRADA.  The Collaborator may request an extension to this term when necessary toprotect Proprietary/Confidential Information relating to products not yet commercialized.                                                                                                                                                                                                                                                        |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8.7                                                 | **Publication. ** TheParties are encouraged to make publicly available the results of their research.  Before either Party submits a paper orabstract for publication or otherwise intends to publicly disclose information about a Subject Invention, Subject Data or ResearchMaterials, the other Party shall be provided thirty (30) days to review the proposed publication or disclosure to assure thatProprietary/Confidential Information is protected.  The publication or other disclosure shall be delayed for up to thirty (30)additional days upon written request by any Party as necessary to preserve U.S. or foreign patent or other IP rights.                                                                                              |
| **Article 9.  Representations and Warranties** |
| 9.1                                                 | **Representations andWarranties of PHS. ** PHS hereby represents and warrants to the Collaborator that the official signing this CRADA hasauthority to do so.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
| 9.2                                                 | **Representations andWarranties of the Collaborator.**
(a)  The Collaborator herebyrepresents and warrants to PHS that the Collaborator has the requisite power and authority to enter into this CRADA and to performaccording to its terms, and that the Collaborator’s official signing this CRADA has authority to do so.  TheCollaborator further represents that it is financially able to satisfy any funding commitments made in Appendix B.

 (b)  The  Collaborator certified that the statementsherein are true, complete, and accurate to the best of its knowledge.  TheCollaborator is aware that any false, fictitious, or fraudulent statements orclaims may subject it to criminal, civil, or administrative penalties. |
| **Article 10.  Termination**                   |
| 10.1                                                | **Termination By MutualConsent. ** PHS and the Collaborator may terminate this CRADA, or portions thereof, at any time by mutual writtenconsent.  In such event the Parties shall specify the disposition of all property, inventions, patent or other IP applicationsand other results of work accomplished or in progress, arising from or performed under this CRADA, all in accordance with therights granted to the Parties under the terms of this Agreement.                                                                                                                                                                                                                                                                                               |
| 10.2                                                | **UnilateralTermination. ** Either PHS or the Collaborator may unilaterally terminate this entire CRADA at any time by giving writtennotice at least thirty (30) days prior to the desired termination date, and any rights accrued in property, patents or other IPrights shall be disposed of as provided in paragraph 10.1.                                                                                                                                                                                                                                                                                                                                                                                                                                         |
| 10.3                                                | **Staffing. **If this CRADA is mutually or unilaterally terminated prior to its expiration, funds will nevertheless remain available to PHS forcontinuing any staff commitment made by the collaborator pursuant to Article 5.1 above and Appendix B, if applicable, for a periodof six (6) months after such termination.  If there are insufficient funds to cover this expense, the Collaborator agrees topay the difference.                                                                                                                                                                                                                                                                                                                                  |

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| 10.4                                | **NewCommitments.**  No Party shall make new commitments related to this CRADA after a mutual termination or notice of aunilateral termination and shall, to the extent feasible, cancel all outstanding commitments and contracts by the terminationdate.                                                                                                                                                                                                                                                                                                                                                                                                                     |
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| 10.5                                | **TerminationCosts.**  Concurrently with the exchange of final reports pursuant to Articles 4.2 and 5.2, PHS shall submit to theCollaborator for payment a statement of all costs incurred prior to the date of termination and for all reasonable terminationcosts including the cost of returning Collaborator property or removal of abandoned property, for which Collaborator shall beresponsible.                                                                                                                                                                                                                                                                        |
| **Article 11.  Disputes**      |
| 11.1                                | **Settlement.**  Anydispute arising under this CRADA which is not disposed of by agreement of the Principal Investigators shall be submitted jointly tothe signatories of this CRADA.  If the signatories are unable to jointly resolve the dispute within thirty (30) days afternotification thereof the Assistant Secretary for Health (or his/her designee or successor) shall propose a resolution. Nothing in this Article shall prevent any Party from pursuing any additional administrative remedies that may be available and,after exhaustion of such administrative remedies, pursing all available judicial remedies.                                    |
| 11.2                                | **Continuation ofWork.**  Pending the resolution of any dispute or claim pursuant to this Article, the Parties agree that performance of allobligations shall be pursued diligently in accordance with the direction of the PHS signatory.                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| **Article 12.  Liability**     |
| 12.1                                | **Property.**  TheU.S. Government shall not be responsible for damages to any Collaborator property provided to PHS, where Collaborator retains titleto the property, or any property acquired by Collaborator for its own use pursuant to this CRADA.                                                                                                                                                                                                                                                                                                                                                                                                                         |
| 12.2                                | **NOWARRANTIES. ** EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTERWHATSOEVER, INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR PRODUCT, WHETHER TANGIBLE OR INTANGIBLE, MADE, ORDEVELOPED UNDER THIS CRADA, OR THE OWNERSHIP MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY INVENTIONOR PRODUCT.                                                                                                                                                                                                                                                                         |
| 12.3                                | **Indemnification.** The Collaborator agrees to hold the U.S. Government harmless and to indemnify the Government for all liabilities, demands, damages,expenses and losses arising out of the use by the Collaborator for any purpose of the Subject Data, Research Materials and/orSubject Inventions produced in whole or party by PHS employee under this CRADA, unless due to the negligence or willful misconductof PHS, its employees, or agents.  The Collaborator shall be liable for any claims or damages it incurs in connection withthis CRADA.  PHS has no authority to indemnify the Collaborator.                                                    |
| 12.4                                | **ForceMajeure.**  Neither Party shall be liable for any unforeseeable event beyond its reasonable control not caused by the faultor negligence of such Party, which causes such Party to be unable to perform its obligations under this CRADA, and which it hasbeen unable to overcome by the exercise of due diligence.  In the event of the occurrence of such a *force majeure*event, the Party unable to perform shall promptly notify the other Party.  It shall further use its best efforts to resumeperformance as quickly as possible and shall suspend performance only for such period of time as is necessary as a result of the*force majeure* event. |
| **Article 13.  Miscellaneous** |
| 13.1                                | **Governing Law.** The construction, validity, performance and effect of this CRADA shall be governed by Federal law, as applied by the Federal Courtsin the District of Columbia.  Federal law and regulations will preempt any conflicting or inconsistent provisions in thisCRADA.                                                                                                                                                                                                                                                                                                                                                                                     |

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| 13.2  | **EntireAgreement.**  This CRADA constitutes the entire agreement between the Parties concerning the subject matter of this CRADAand supersedes any prior understanding or written or oral agreement.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
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| 13.3  |  **Headings.**  Titlesand headings of the articles and subarticles of this CRADA are for convenient reference only, do not form a part of this CRADA, andshall in no way affect its interpretation.  The PHS component that is the Party for all purposes of this CRADA is theBureau(s), Institute(s), Center(s) or Division(s) listed on the Cover Page herein.                                                                                                                                                                                                                                                                                                                                                                           |
| 13.4  | **Waivers.**  None ofthe provisions of this CRADA shall be considered waived by any Party unless such waiver is given in writing to the otherParty.  The failure of a Party to insist upon strict performance of any of the terms and conditions hereof, or failure ordelay to exercise any rights provided herein or by law, shall not be deemed a waiver of any rights of any Party.                                                                                                                                                                                                                                                                                                                                                          |
| 13.5  | **Severability. **The illegality or invalidity of any provisions of this CRADA shall not impair, affect, or invalidate the other provisions of thisCRADA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 13.6  | **Amendments.**  Ifeither Party desires a modification to this CRADA, the Parties shall, upon reasonable notice of the proposed modifications orextension by the Party desiring the change, confer in good faith to determine the desirability of such modification orextension.  Such modification shall not be effective until a written amendment is signed by the signatories to this CRADA orby their representatives duly authorized to execute such amendment.                                                                                                                                                                                                                                                                           |
| 13.7  | **Assignment.** Neither this CRADA nor any rights or obligations of any Party hereunder shall be    assigned or otherwise transferred by either Party without the prior written    consent of the other Party.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
| 13.8  | **Notices.** All notices pertaining to or required by this CRADA shall be in writing and shall be signed by an authorized representative andshall be delivered by hand or sent by certified mail, return receipt requested, with postage prepaid, to the addresses indicated onthe signature page for each Party.  Notices regarding the exercise of license options shall be made pursuant to Article7.2.  Any Party may change such address by notice given to the other Party in the manner set forth above.                                                                                                                                                                                                                            |
| 13.9  | **IndependentContractors.**  The relationship of the Parties to this CRADA is that of independent contractors and not agents of eachother or joint venturers or partners.  Each Party shall maintain sole and exclusive control over its personnel andoperations.  Collaborator employees who will be working at PHS facilities may be asked to sign a Guest Researcher or SpecialVolunteer Agreement appropriately modified in view of the terms of this CRADA.                                                                                                                                                                                                                                                                           |
| 13.10 | **Use of Name orEndorsements.**  By entering into this CRADA, PHS does not directly or indirectly endorse any product or service provided,or to be provided, whether directly or indirectly related to either this CRADA or to any patent or other IP license or agreementwhich implements this CRADA by its successors, assignees, or licensees.  The Collaborator shall not in any way state or implythat this CRADA is an endorsement of any such product or service by the U.S. Government or any of its organizational units oremployees.  Collaborator issued press releases that reference or rely upon the work of PHS under this CRADA shall be madeavailable to PHS at least 7 days prior to publication for review and comment. |
| 13.11 | **Exceptions to thisCRADA**.  Any exceptions or modifications to this CRADA that are agreed to by the Parties prior to their execution of thisCRADA are set forth in Appendix C.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 13.12 | **ReasonableConsent.**  Whenever a Party's consent or permission is required under this CRADA, such consent or permission shall not beunreasonably withheld.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |

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| **Article 14.  Duration of Agreement** |
|---------------------------------------------|
| 14.1                                        | **Duration.**  It ismutually recognized that the duration of this project cannot be rigidly defined in advance, and that the contemplated time periodsfor various phases of the RP are only good faith guidelines subject to adjustment by mutual agreement to fit circumstances as theRP proceeds.  In no case will the term of this CRADA extend beyond the term indicated in the RP unless it is revised inaccordance with Article 13.6. |
| 14.2                                        | **Survivability.** The provisions of Articles 4.2, 5-8, 10.3-10.5, 11.1, 12.2-12.4, 13.1, 13.10 and 14.2 shall survive the termination of thisCRADA. |

 

 

 

 

**SIGNATURES BEGIN ON THE NEXT PAGE**

 

Page 10 of 18

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**CRADA SIGNATURE PAGE**

By executing this Agreement, each of the undersigned represents and confirmsthat he or she is fully authorized to bind the identified entity to its terms.  Each of the undersigned expressly certified oraffirms that the contents of any statement made or reflected in this document are truthful and accurate.

| **AGREED TO AND ACCEPTED BY:**                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                       |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                       |
| **For the National Cancer Institute:**                                                                                                                                                              |                                                                                                                                                                                                                                                                                                                                                                       |
|                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                       |
|  /s/ Alan S.Rabson            **Alan S. Rabson, M.D.        Deputy Director, NCI**                                                 |  7/14/99                                                  **           Date** |
|                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                       |
| Mailing Address for Notices:
National Cancer Institute    Technology Development and Commercialization Branch    Executive Plaza South, Room 450    6120 Executive Boulevard    Rockville, MD 20852 |                                                                                                                                                                                                                                                                                                                                                                       |
|                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                       |
|  **For ASTA Medica, Inc.:**                                                                                                                                                                    |                                                                                                                                                                                                                                                                                                                                                                       |
|                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                       |
| **_______________________________Colin Stewart    Chief Executive Officer, ASTA Medica, Inc.**                                                                                                      |  ______________________**                  Date **                                                                                                                                                                                                                                         |
| ** **                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                                                                       |
| ** **                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                                                                       |
| Mailing Address for Notices:
ASTA Medica, Inc.    890 East Street    Tewsksbury, MA 01876                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                       |

 

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