Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Janssen, COVID-19 Vaccine Large Scale Manufacturing Agreement

  • Intellectual Property | Exploitation of results
  • Intellectual Property | Ownership of background IP
  • Intellectual Property | Ownership of results
  • Intellectual Property | Protection of IP
  • Intellectual Property | Use of background IP

Definitions

Data” means Recorded information first created in performance of the Project, regardless of form or method of recording, which includes but is not limited to, technical data and software, but does not include Subject Inventions, production/manufacturing know-how, trade secrets, clinical data, or financial, administrative, cost, pricing or management information.

IX. Patent Rights

IX.1 Background Intellectual Property Disclosures. Janssen asserts full title to all background intellectual property relevant to its performance of this statement of work and listed at Attachment 1. Janssen hereby conveys a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States to the “Licensed Patents” throughout the world for the prevention, diagnosis and treatment of COVID-19 caused by Severe Respiratory Syndrome-Coronavirus-2 (SARS CoV-2). “Licensed Patents” means US Provisional Patent Application Serial No. (b) (4) [REDACTED] as well as any and all patent applications and patents (including any counterparts, PCT’s, national stage applications, divisionals, continuations, or the like thereof, and any extensions thereof), wherever filed in the world, that claim priority to US Patent Application Serial No. ……. [REDACTED]. The Parties agree that nothing in this Project Agreement will otherwise alter the existing patent rights of the Parties unless expressly agreed upon. 

IX.2 Allocation of Principle Rights. If Janssen elects to retain title to a Subject Invention, Janssen or its designee shall retain the entire right, title, and interest throughout the world to each Subject Invention developed under this Project Agreement consistent with the provisions of this Article and 35 U.S.0 § 202 subject to the retention by the Government of a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States any Subject Invention. The license retained by the Government does not include the right to use or allow others to use the Subject Invention for commercial purposes. 

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. 

b. Where publication, sale, or public use has initiated the one (1)-year statutory period wherein valid patent protection can still be obtained in the United States, the period for such notice of election may be shortened by the Government to a date that is no more than sixty (60) calendar days prior to the end of the statutory period. 

c. If electing title, Janssen will file its initial patent application on a Subject Invention to which it elects to retain title within one year after election of title, or, if earlier, prior to the end of the statutory period wherein valid patent protection can be obtained in the United States after a publication, or sale, or public use. 

d. Foreign Patent Filing Requirements: Janssen may elect to file corresponding patent applications in additional countries outside the U.S. (including but not limited to the European Patent Office and the Patent Cooperation Treaty) at its discretion. To enable the Government to protect patent rights in Subject Inventions in all potential countries, Janssen shall inform the Government of which countries Janssen shall NOT file patents applications in for all elected Subject Inventions at least 3 months prior to the filing deadline therein (e.g., in PCT national stage applications, at least 3 months prior to the PCT national stage filing deadline). Janssen understands that, in case the Government decides to file in a particular country following a notice provided under the preceding sentence, all ownership and interest in Subject Inventions in said countries (where Janssen shall not file patent applications in) are thereby automatically conveyed to the Government, and Janssen agrees to timely execute any documentation required to effectuate this conveyance, so as to enable the Government to perfect patent filing in said countries, always subject to the license described in Article IX, Section 5(a). 

e. If Janssen does not elect title via the process described above, or determines that neither it nor its designee intends to file any patent applications on a Subject Invention, Janssen shall notify the Government, in writing, within 6 months of disclosure of such Subject Invention to the Government. Janssen agrees, in such case, to permit the Government to elect title to said Subject Invention, and thereby have full rights and ownership therein, at least 3 months PRIOR to the end of the one (1)-year statutory period wherein valid patent protection can still be obtained in the United States after any publication, sale, or public use. 

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. 

g. Neither Party will publicly disclose any Subject Invention until a patent application describing the Subject Invention is filed, or a reasonable period of time has passed in the event that a patent application is not filed, in order to protect the patentability of the invention pursuant to 35 U.S.C. § 205.

IX.4 Conditions When the Government May Obtain Title. Upon JPEO-CBRND’s written request, Janssen shall convey title to the Government: 

a. Of any Subject Invention, if Janssen fails to disclose the Subject Invention or elects not to retain title to the Subject Invention within the times specified in Article IX, Section 3(a) and (b), the Government may request title for a period of up to 60 calendar days after learning of the failure of Janssen to disclose within the specified times. For the avoidance of doubt, disclosure under this paragraph shall be deemed to have occurred at the time of Janssen’s notification to JPEO-CBRND of a Subject Invention regardless of whether such disclosure meets the standards set forth in Article IX, Section 3(a) above. 

b. Of a patent application or patent that claims a Subject Invention, as the case may be, in any country in which Janssen decides not to continue the prosecution of such patent application, or to pay the maintenance fees on or defend in reexamination or opposition proceedings such a patent. 

IX.5 Minimum Rights to Janssen’s Consortium and Protection of Janssen’s Consortium’s Right to File. 

a. Janssen shall retain a nonexclusive, royalty-free license throughout the world in each Subject Invention to which JPEO-CBRND obtains title under Article IX, Section 8. The Janssen license extends to the Janssen’s Affiliates, and includes the right to grant licenses of the same scope to the extent that Janssen was legally obligated to do so at the time the Project Agreement was awarded or at the time of the Subject Invention was invented. The license is transferable only with the approval of JPEO-CBRND, except when transferred to the successor of that part of the business to which the Subject Invention pertains. JPEO-CBRND approval for license transfer shall not be unreasonably withheld. 

b. The Janssen license may be revoked or modified by the Government to the extent necessary to achieve expeditious Practical Application of the Subject Invention pursuant to an application for an exclusive or non-exclusive license submitted consistent with appropriate provisions at 37 CFR Part 404. 

c. Before modification of the license, JPEO-CBRND shall furnish Janssen a written notice of its intention to revoke or modify the license, and Janssen shall be allowed thirty (30) calendar days (or such other time as may be authorized for good cause shown) after the notice to show cause why the license should not be modified. 

IX.6 Action to Protect JPEO-CBRND’s Interest 

a. Janssen agrees to execute or to have executed and promptly deliver to JPEO-CBRND all instruments necessary to (i) establish or confirm the rights JPEO-CBRND has throughout the world in those Subject Inventions to which Janssen elects to retain title, and (ii) convey title to JPEO-CBRND when requested under Section 4 of this Article IX and to enable JPEO-CBRND to obtain patent protection throughout the world in that Subject Invention. 

b. Janssen agrees to require, by written agreement, its employees, other than clerical and non-technical employees, to disclose promptly in writing, to personnel identified as responsible for the administration of patent matters and in a format suggested by Janssen, each Subject Invention in order that Janssen can comply with the disclosure provisions of Section 3 of this Article IX. Janssen shall instruct employees, through employee agreements or other suitable educational programs, on the importance of reporting Subject Inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars. 

c. Janssen shall notify JPEO-CBRND of any decisions not to continue the prosecution of a patent application claiming a Subject Invention, pay maintenance fees on a patent claiming a Subject Invention, or defend in a reexamination or opposition proceedings on a patent claiming a Subject Invention, in any country, not less than sixty (60) calendar days before the expiration of the response period required by the relevant patent office. 

d. Janssen shall include, within the specification of any United States patent application and any patent issuing thereon claiming a Subject Invention, the following statement: “This invention was made with Government support under Agreement [W15QKN-19-6-1002, 2011-004], awarded by JPEO-CBRND. JPEO-CBRND has certain rights in the 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. 

c. Where the Subject Invention is a drug or a vaccine, or a method of manufacturing, administering or using a drug or vaccine, Practical Application in view of the March-in Rights in Article IX, Section 8 below is achieved with respect to: 

(i) such drug or vaccine, if a Phase Ila clinical study is completed that studies such drug or vaccine; or 

(ii) such method of use, if the method of use is employed in manufacture, administration or use of such drug or vaccine in connection with a Phase Ila clinical study. 

d. Failure to complete a Phase Ila clinical study does not per se constitute a failure to achieve Practical Application.

IX.9 Background Information. Janssen shall retain the entire right, title, and interest throughout the world to each such Invention and Patent that Janssen has brought to the Prototype Project issued under this Project Agreement/Statement of Work and the Government shall not have any rights under this Project Agreement/Statement of Work to such Inventions and Patents unless identified herein. Attachment 1 to the Project Agreement contains non-exhaustive overview of Janssen’s Background Patents, patent applications and Inventions at the Effective Date. Table 10-1 [table redacted] in Article X “Data Rights” provides a non-exhaustive overview of Data Rights, information and Technical Data that Janssen will bring to the Project Agreement at the Effective Date. The Government shall have no rights to these Background Inventions, Patents, information and Technical Data and any further Background Inventions, Patents, information and Technical Data identified during the Term of the Project Agreement or afterwards.

X. Data Rights 

X.1 Data Categories. Article XI of the Agreement, is hereby superseded by the following terms and conditions: There are two (2) categories of Data or other information established under this Project Agreement as listed below. 

a. Category A is Data or other information to which Janssen retains all rights. Category A Data shall include, but not be limited to: 

(i) Data as defined in the Project Agreement, background (i.e., pre-existing or generated outside the scope of this Project Agreement) information and Technical Data identified in Table 10-1 (TABLE REDACTED) and Attachment 1 (background Patents, patent applications and Inventions), and any designs or other material provided by Janssen for this Project Agreement which was not developed in the performance of work under this project, and to which Janssen retains rights. 

(ii) The Parties hereby mutually agree that any information developed outside of this Project Agreement whether or not developed with any Government funding in whole or in part under a Government agreement, contract or subcontract shall have the rights negotiated under such prior agreement, contract or subcontract; the Government shall get no additional rights in such information.

b. Category B is any Data developed exclusively with Government funds under this Project Agreement. 

(i) The Government will have Government Purpose Rights in Data developed exclusively with Government funds under this Project Agreement. 

(ii) The Government shall have unlimited rights in Data: (a) Otherwise publicly available or that has been released or disclosed by Janssen without restrictions on further use, release or disclosure, other than a release or disclosure resulting from the sale, transfer, or other assignment of interest in the Data to another party or the sale or transfer of some or all of a business entity or its assets to another party; (b) Data in which the Government has obtained unlimited rights under another Government contract or as a result of negotiations; or (c) Data furnished to the Government, under this or any other Government contract or subcontract thereunder, with1. government purpose rights or limited rights and the restrictive condition(s) has/have expired; or 2. Government purpose rights and Janssen’s exclusive right to use such Data for commercial purposes under such contract or subcontract has expired. 

(iii) However, any Data or other information developed outside of this OTA whether or not developed with any Government funding in whole or in part under a Government agreement, contract or subcontract shall have the rights negotiated under such prior agreement, contract or subcontract; the Government shall get no additional rights in such Data or other information. 

X.2 Allocation of Principle Rights 

a. The Government shall have no rights to Category A Data or other information, but shall have rights to Deliverables as described in Table 1-5. 

b. The Government will receive Government Purpose Rights in Data or other information exclusively funded by the Government and otherwise Limited Rights in any data delivered in the performance of the SOW. To the extent that the Parties mutually agree that there will be Data subject to Government Purpose Rights, Data subject to Government Purpose Rights may only be shared with parties outside the Government when such parties are subject to the non-disclosure agreement at DFARS 227.7103-7 with respect to the data or are receiving the data under a Government contract subject to DFARS 252.227-7025. Any delivered Data or other information which is part of a patent application claiming a Subject Invention will be subject to the disclosure and release restrictions set forth in Article X, Section 2 of this Project Agreement. 

c. Data or other information in any document which is a part of a patent application that would disclose a Subject Invention will be subject to Limited Rights until publication of patent application in accordance with Article X of this Project Agreement/Statement of Work. 

d. Janssen agrees to retain and maintain in good condition all Data necessary to achieve Practical Application of any Subject Invention in accordance with the Janssen’s established record retention practices. In the event of exercise of the Government’s March-in Rights as set forth under Article X, Janssen agrees, upon written request and with adequate additional support from the Government, as mutually agreed between the Parties, to deliver Data necessary to achieve Practical Application within one-hundred and twenty (120) calendar days from the date of the written request. 

e. Janssen’s right to use Data is not restricted and includes the right under Janssen’s established business policies to make public research data (especially human research data) by publication in the scientific literature, by making trial protocols, trial results summaries, and clinical studies reports publicly available, and by making trial patient-level data available for third-party analysis. The Government agrees that the materials, if any, being developed under this Project Agreement/Statement of Work are being developed for both civilian and military applications. 

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.”