3.1        MCGRI agrees to complete case report forms under the Study promptly and to deliver these forms and any other necessary data related to the Study to representatives of Sponsor at periodic monitoring visits.  All such information and material will become the property of Sponsor and may be freely utilized by Sponsor in any manner desired.  MCGRI further agrees to assist Sponsor's representatives in resolving any discrepancies or errors in case report forms and in performing random audits of original case records, laboratory reports and/or other raw data sources underlying data recorded on the case report forms.  Sponsor will send copies of the final corrected case report forms to the Principal Investigator when complete.

3.2        MCGRI shall retain copies of all documentation relating to this Study as required by federal, state or local laws or regulations or by the Protocol, until all obligations of all persons associated with the Study have been completed.

3.3        During the term of this Agreement, representatives of MCGRI may meet with representatives of Sponsor at times and places mutually agreed upon to discuss the progress and results as well as ongoing plans, or changes therein, of the Study to be performed hereunder. 

3.4        Sponsor will notify MCGRI prior to or concurrent with any monitoring visits.

ARTICLE 4 - CONFIDENTIALITY

4.1        MCGRI and MCG shall use that care which they use to protect their own confidential information not to disclose to any third party any information or data provided by Sponsor to MCGRI in connection with the Study and the Protocol which is marked by Sponsor as confidential or with a similar legend, or which is reduced to writing within 30 days after disclosure and designated as confidential ("Confidential Information").  Such confidentiality obligation shall be observed during the performance of the Study and for a period of three years following the termination or expiration date of this Agreement.  Confidential Information shall be returned to Sponsor to the extent possible upon completion by MCGRI of its obligations under this agreement or upon demand.

4.2        The obligation to protect Sponsor's Confidential Information shall not apply to any information that:

             (1)      is already in the possession of, or is independently developed by, MCGRI as evidenced by written record,

             (2)      is or becomes publicly available other than through breach of MCGRI's confidentiality obligations,

             (3)      is received by MCGRI from a third party without either knowledge of origination in Sponsor or obligation of confidence,

             (4)      is released for disclosure by Sponsor with its written consent, or

             (5)      is required to be disclosed by law, regulation or court order, including but not limited to the Georgia Open Records Act (providing that MCGRI has taken all reasonable efforts to keep information confidential to the extent permitted by such Act).

ARTICLE 5 - PUBLICATIONS

5.1        Sponsor recognizes that under MCGRI and MCG policy, the results of the Study must be publishable and agrees that researchers engaged in the Study shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of their own choosing, methods and results of the Study, provided, however, that Sponsor shall have been furnished copies of any proposed publication or presentation at least one month in advance of the submission of such proposed publication or presentation to a journal, editor, or other third party.  Sponsor shall have 30 days after receipt of said copies, to object to such proposed presentation or proposed publication because there is patentable subject matter which needs protection.  In the event that Sponsor makes such objection, said researcher(s) shall refrain from making such publication or presentation for a maximum of four months from date of receipt of such objection in order for MCGRI to file patent application(s) with the United States Patent and Trademark Office or foreign patent office(s) directed to the patentable subject matter contained in the proposed publication or presentation.

ARTICLE 6 - INTELLECTUAL PROPERTY

6.1        MCGRI agrees that it has no proprietary rights to or interest in (DRUG/DEVICE BEING STUDIED) (hereinafter  "Product").  MCGRI further agrees that Sponsor owns all the rights to the Product.  Rights to inventions, improvements and discoveries, whether or not patentable or copyrightable, relating to the Study made solely by employees of Sponsor shall belong to Sponsor.  Such inventions, improvements, and discoveries shall not be subject to the terms and conditions of this Agreement.

6.2        All rights and title to MCGRI Intellectual Property under the Study shall belong to MCGRI, subject to the right of Sponsor to take an exclusive, or non-exclusive, royalty-bearing license to MCGRI Intellectual Property, as set forth in Article 7, below and shall be subject to the terms and conditions of this Agreement.  "MCGRI Intellectual Property" shall mean individually and collectively all inventions, improvements or discoveries which are conceived or made by one or more employees of MCG in performance of the Study during Agreement Period.

6.3        MCGRI will promptly notify Sponsor of any MCGRI Intellectual Property.  If Sponsor directs or MCGRI determines that a patent application or application for other intellectual property protection should be filed, MCGRI shall promptly prepare, file and prosecute such U. S. or foreign application in MCGRI's name.  If Sponsor directs MCGRI to file a patent application hereunder or desires to maintain its right to exercise either option (a) or (b) of Section 7.2, below, Sponsor shall bear all costs incurred in connection with such preparation, filing, prosecution and maintenance of U. S. and foreign application(s).  Sponsor shall cooperate with MCGRI to assure that such application(s) will cover, to the best of Sponsor's knowledge, all items of commercial interest and importance.  While MCGRI shall be responsible for making decisions regarding scope and content of application(s) to be filed and prosecution thereof, Sponsor shall be given an opportunity to review and provide input thereto.  MCGRI shall inform Sponsor of all developments with respect to such application(s) and shall promptly supply to Sponsor copies of all papers received and filed in connection with the prosecution thereof in sufficient time for Sponsor to comment thereon.

6.4      If Sponsor elects not to exercise its option as described below or decides to discontinue the financial support of the prosecution or maintenance of the protection, MCGRI shall be free to file or continue prosecution or maintain any such application(s), and to maintain any protection issuing thereon in the U. S. and in any foreign country at MCGRI's sole expense.  MCGRI hereby grants Sponsor a royalty-free, non-exclusive license to use MCGRI Intellectual Property within its own organization for any noncommercial purpose. MCGRI hereby grants the first option, at Sponsor's sole selection, for either (a) a non-exclusive, royalty-bearing license to use MCGRI Intellectual Property for any purpose except sublicensing, or (b) an exclusive royalty-bearing license with a right to sublicense. Terms and conditions of these licenses are to be negotiated in good faith and agreed upon between MCGRI and Sponsor. Provided Sponsor has participated in bearing patent expenses as described above, this option shall extend for a period of sixty days from the termination date of this Agreement. In the event that Sponsor acquires an exclusive license or right under this Agreement, Sponsor hereby grants to MCGRI the right to continue to use MCGRI Intellectual Property for any noncommercial purpose.

ARTICLE 7 - GRANT OF RIGHTS

7.1        MCGRI hereby grants Sponsor a royalty-free, non-exclusive license to use MCGRI Intellectual Property within its own organization for any noncommercial purpose.

7.2        MCGRI hereby grants the first option, at Sponsor's sole selection, for either (a) a non-exclusive, royalty-bearing license to use MCGRI Intellectual Property for any purpose except sublicensing, or (b) an exclusive royalty-bearing license with a right to sublicense.  Terms and conditions of these licenses are to be negotiated in good faith and agreed upon between MCGRI and Sponsor.  Provided Sponsor has participated in bearing patent expenses as described in Section 6.3, above, this option shall extend for a period of sixty days from the termination date of this Agreement.

7.3        In the event that Sponsor acquires an exclusive license or right under this Agreement, Sponsor hereby grants to MCGRI the right to continue to use MCGRI Intellectual Property for any noncommercial purpose.

ARTICLE 8 - TERM AND TERMINATION

8.1        This Agreement shall become effective upon the date first written above and shall continue in effect for the full duration of the Agreement Period, as specified in Article 1.5.  The parties hereto may, however, extend the term of this Agreement for additional periods as desired under mutually agreeable terms and conditions which the parties reduce to writing and sign. 

8.2        This Study may be terminated at any time by MCGRI for any valid cause or if required to protect patient safety (e.g., due to the occurrence of serious or unexpected adverse reactions) or by Sponsor for any valid cause, by either party's giving thirty (30) days written notice to the other party.  If this Study is terminated prior to completion, MCGRI shall furnish to Sponsor all case report forms, either completed or uncompleted, up to the date of termination, as well as all other Study materials, including but not limited to the Study Product.

8.3        No termination of this Agreement, however effectuated, shall release the parties from their rights and obligations accrued prior to the effective date of termination.

ARTICLE 9 - INDEMNIFICATION AND INSURANCE

9.1        Sponsor agrees to indemnify and hold harmless MCGRI and its duly authorized agents, servants and employees from all claims, demands, actions, causes of action and suites of whatever kind or nature and to indemnify MCGRI and its duly authorized agents, servants and employees from all damages, losses, judgments, costs and fees, including attorneys' fees, which result from this Study, provided that:

             (1)      MCGRI, and its agents, servants and employees have followed the Protocol described herein as Exhibit A and were not negligent in conducting the work under Protocol; and

             (2)      MCGRI promptly gives SPONSOR notice of, and the right to defend against, any claim or suit as well as the unconditional right to settlement of such suits in the sole discretion of SPONSOR; and

             (3)      MCGRI agrees to cooperate fully with SPONSOR in its defense of any claim or suit.

9.2        MCGRI warrants and represents that MCG has adequate liability insurance, such protection being applicable to officers, employees, and agents while acting within the scope of their employment by MCG.  MCG has no liability insurance policy as such that can extend protection to any other person.

9.3        Sponsor acknowledges that this Agreement does not confer upon Sponsor any right of claim of indemnification by the MCGRI or MCG, either express or implied.