IX. Patent Rights
IX.3 Invention Disclosure, Election of Title, and Filing of Patent Application
a. Janssen shall disclose each Subject Invention to the Government within two (2) months of the Subject Invention being disclosed in writing to the person responsible for Janssen patent matters. The Subject Invention shall be disclosed in writing to the Government, via appropriate filings in the iEdison system or its replacement/alternative system, with a copy of said reporting being sent to JPEO–CBRND. Further, Janssen shall elect in writing whether or not to retain title to any such invention by notifying the Government within 6 months of disclosure to the Government.
f. In addition to the reporting required above, Janssen shall identify Subject Inventions in an annual report and the final report, which shall be in sufficiently complete technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the Subject Invention.
IX.7 Reporting on Utilization of Subject Inventions
a. Janssen shall submit, during the term of the Project Agreement, an annual report on the utilization of Subject Inventions or on efforts at obtaining such utilization that are being made by or on behalf of Janssen or its licensees or assignees. Such reports will include information regarding the status of development, date of first commercial sale or use, and such other data and information as the agency may reasonably specify. Janssen shall provide additional reports as may be requested by JPEO–CBRND in connection with any march–in proceedings undertaken by the Government in accordance with Article IX, Section 8 of this Project Agreement. Consistent with 35 U.S.C. § 202I (5), JPEO–CBRND agrees it shall not disclose such information to persons outside JPEO–CBRND without permission of Janssen.
b. All required reporting shall be submitted to the AO and AOR.
X. Data Rights
X.3 Identification and Disposition of Data. Janssen shall keep copies of all Data required by the FDA relevant to this Project Agreement for the time specified by the FDA and provide such Data to AO. The Government reserves the right to review any other Data determined by the Government to be relevant to this Project Agreement/Statement of Work subject to Limited Rights.
a. Marking of Data Pursuant to section A above, any Data delivered under this Project Agreement/Statement of Work that is subject to Government Purpose Rights shall be marked with the following legend or similar: “GOVERNMENT PURPOSE RIGHTS: The Government’s right to use, modify, reproduce, perform, display or disclose this Data is restricted by P00081 Modification to the MCDC OTA No. W15QKN–16–9–1002 between the Government, ATI and Janssen, and those restrictions do not permit disclosure to any party outside the Government unless such disclosure is for government purposes and not facilitating commercial sale beyond the government. Any reproduction of this Data or portions thereof must be marked with this legend.”
b. Pursuant to section A above, any Data delivered under this Project Agreement/Statement of Work that is subject to Limited Rights shall be marked with the following legend or similar: “LIMITED RIGHTS: The Government’s right to use, modify, reproduce, perform, display or disclose this Data is restricted by P00081 Modification to the MCDC OTA No. W150KN–16–9–1002 between the Government, ATI and Janssen, and those restrictions do not permit disclosure to any party outside the Government without prior agreement of Recipient. Any reproduction of this Data or portions thereof must be marked with this legend.”