Master Alliance Provisions Guide (MAPGuide)

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

  • IP ownership & licensing | Exploitation of results
  • IP ownership & licensing | Ownership of background IP
  • IP ownership & licensing | Ownership of results
  • IP ownership & licensing | Protection of IP
  • IP ownership & licensing | Use of background IP

<p><span style=”textdecoration: underline;”><b>IX. Patent Rightsb>span>p>
<p><b>IX.1 Background Intellectual Property Disclosures. b><span style=”fontweight: 400;”>Janssen asserts full title to all span><span style=”fontweight: 400;”>background intellectual propertyspan><span style=”fontweight: 400;”> relevant to its performance of this statement of work and listed at Attachment 1. Janssen hereby conveys a nonexclusive, nontransferable, irrevocable, paidup license to practice or have practiced for or on behalf of the United States to the &#8220;Licensed Patents&#8221; throughout the world for the prevention, diagnosis and treatment of COVID19 caused by Severe Respiratory SyndromeCoronavirus2 (SARS CoV2). &#8220;span><b><i>Licensed Patentsi>b><span style=”fontweight: 400;”>&#8221; means US Provisional Patent Application Serial No. (b) (4) [REDACTED] as well as any and all patent applications and patents (including any counterparts, PCTs, 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 uponspan>p>
<p><b>IX.2 Allocation of Principle Rights. b><span style=”fontweight: 400;”>If Janssen elects to retain title to a <a href=”#kt“>Subject Inventiona>span><span style=”fontweight: 400;”>, 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, paidup 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 purposesspan>p>
<p><b>IX.3 Invention Disclosure, Election of Title, and Filing of Patent Application b>p>
<p><span style=”fontweight: 400;”>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 JPEOCBRND. 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 Governmentspan>p>
<p><span style=”fontweight: 400;”>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 periodspan>p>
<p><span style=”fontweight: 400;”>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 usespan>p>
<p><span style=”fontweight: 400;”>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). span>p>
<p><span style=”fontweight: 400;”>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 usespan>p>
<p><span style=”fontweight: 400;”>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 Inventionspan>p>
<p><span style=”fontweight: 400;”>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.span>p>
<p><b>IX.4 Conditions When the Government May Obtain Title. b><span style=”fontweight: 400;”>Upon <a href=”#kt“>JPEOCBRNDa>’s written request, Janssen shall convey title to the Governmentspan>p>
<p><span style=”fontweight: 400;”>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 Janssens notification to JPEOCBRND of a Subject Invention regardless of whether such disclosure meets the standards set forth in Article IX, Section 3(a) abovespan>p>
<p><span style=”fontweight: 400;”>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 patentspan>p>
<p><b>IX.5 Minimum Rights to Janssens Consortium and Protection of Janssens Consortiums Right to Fileb>p>
<p><span style=”fontweight: 400;”>a. Janssen shall retain a nonexclusive, royaltyfree license throughout the world in each Subject Invention to which JPEOCBRND obtains title under <a href=”https://ghiaa.org/provision_document/usdepartmentofdefensejanssencovid19vaccinelargescalemanufacturingagreement3/” target=”_blankrel=”noopener“>Article IX, Section 8a>. The Janssen license extends to the Janssens 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 JPEOCBRND, except when transferred to the successor of that part of the business to which the Subject Invention pertains. JPEOCBRND approval for license transfer shall not be unreasonably withheldspan>p>
<p><span style=”fontweight: 400;”>b. The Janssen license may be revoked or modified by the Government to the extent necessary to achieve expeditious <a href=”#kt“>Practical Applicationa> of the Subject Invention pursuant to an application for an exclusive or nonexclusive license submitted consistent with appropriate provisions at 37 CFR Part 404span>p>
<p><span style=”fontweight: 400;”>c. Before modification of the license, JPEOCBRND 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 modifiedspan>p>
<p><b>IX.6 Action to Protect JPEOCBRNDs Interestb><span style=”fontweight: 400;”> span>p>
<p><span style=”fontweight: 400;”>a. Janssen agrees to execute or to have executed and promptly deliver to JPEOCBRND all instruments necessary to (i) establish or confirm the rights JPEOCBRND has throughout the world in those Subject Inventions to which Janssen elects to retain title, and (ii) convey title to JPEOCBRND when requested under Section 4 of this Article IX and to enable JPEOCBRND to obtain patent protection throughout the world in that Subject Inventionspan>p>
<p><span style=”fontweight: 400;”>b. Janssen agrees to require, by written agreement, its employees, other than clerical and nontechnical 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 barsspan>p>
<p><span style=”fontweight: 400;”>c. Janssen shall notify JPEOCBRND 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 officespan>p>
<p><span style=”fontweight: 400;”>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 [W15QKN1961002, 2011004], awarded by JPEOCBRND. JPEOCBRND has certain rights in the invention.” span>p>
<p><b>IX.7 Reporting on Utilization of Subject Inventionsb><span style=”fontweight: 400;”> span>p>
<p><span style=”fontweight: 400;”>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 JPEOCBRND in connection with any marchin proceedings undertaken by the Government in accordance with Article IX, Section 8 of this Project Agreement. Consistent with 35 U.S.C. § 202I (5), JPEOCBRND agrees it shall not disclose such information to persons outside JPEOCBRND without permission of Janssen.  span>p>
<p><span style=”fontweight: 400;”>b. All required reporting shall be submitted to the AO and AORspan>p>
<p><span style=”fontweight: 400;”>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 Marchin Rights in Article IX, Section 8 below is achieved with respect tospan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(i) such drug or vaccine, if a Phase Ila clinical study is completed that studies such drug or vaccine; or span>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(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 studyspan>p>
<p><span style=”fontweight: 400;”>d. Failure to complete a Phase Ila clinical study does not per se constitute a failure to achieve Practical Application.span>p>
<p><b>IX.9 Background Informationb><span style=”fontweight: 400;”>. span><span style=”fontweight: 400;”>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 nonexhaustive overview of Janssens Background Patents, patent applications and Inventions at the Effective Date. Table 101 [table redacted] in Article XData Rightsprovides a nonexhaustive 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.span>p>
<p><span style=”textdecoration: underline;”><b>X. Data Rights b>span>p>
<p><b>X.1 Data Categories. b><span style=”fontweight: 400;”>Article XI of the Agreement, is hereby superseded by the following terms and conditions: There are two (2) categories of Data<sup><a id=”ref1href=”#fn1“>[1]a>sup> or other information established under this Project Agreement as listed belowspan>p>
<p><span style=”fontweight: 400;”>a. Category A is Data or other information to which Janssen retains all rights. Category A Data shall include, but not be limited tospan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(i) Data as defined in the Project Agreement, background (i.e., preexisting or generated outside the scope of this Project Agreement) information and Technical Data identified in Table 101 (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 rightsspan>p>
<p style=”paddingleft: 25px;”>(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.p>
<p><span style=”fontweight: 400;”>b. Category B is any Data developed exclusively with Government funds under this Project Agreementspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(i) The Government will have <a href=”#kt“>Government Purpose Rightsa> in Data developed exclusively with Government funds under this Project Agreementspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(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&#8217;s exclusive right to use such Data for commercial purposes under such contract or subcontract has expiredspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(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 informationspan>p>
<p><b>X.2 Allocation of Principle Rightsb><span style=”fontweight: 400;”> span>p>
<p><span style=”fontweight: 400;”>a. The Government shall have no rights to Category A Data or other information, but shall have rights to Deliverables as described in Table 15span>p>
<p><span style=”fontweight: 400;”>b. The Government will receive Government Purpose Rights in Data or other information exclusively funded by the Government and otherwise <a href=”#kt“>Limited Rightsa> 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 nondisclosure agreement at DFARS 227.71037 with respect to the data or are receiving the data under a Government contract subject to DFARS 252.2277025. 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 Agreementspan>p>
<p><span style=”fontweight: 400;”>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 Workspan>p>
<p><span style=”fontweight: 400;”>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&#8217;s established record retention practices. In the event of exercise of the Government&#8217;s Marchin 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 onehundred and twenty (120) calendar days from the date of the written requestspan>p>
<p><span style=”fontweight: 400;”>e. Janssen&#8217;s right to use Data is not restricted and includes the right under Janssen&#8217;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 patientlevel data available for thirdparty 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 applicationsspan>p>
<p><b>X.3 Identification and Disposition of Data.b><span style=”fontweight: 400;”> span><span style=”fontweight: 400;”>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 Rightsspan>p>
<p><span style=”fontweight: 400;”>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: &#8220;GOVERNMENT PURPOSE RIGHTS: The Government&#8217;s right to use, modify, reproduce, perform, display or disclose this Data is restricted by P00081 Modification to the MCDC OTA No. W15QKN1691002 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.&#8221span>p>
<p><span style=”fontweight: 400;”>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: &#8220;LIMITED RIGHTS: The Government&#8217;s right to use, modify, reproduce, perform, display or disclose this Data is restricted by P00081 Modification to the MCDC OTA No. W150KN1691002 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.&#8221;span>p>
<p><sup id=”fn1“><a href=”#ref1“>[1]a>sup>“<b><i>Datai>b><span style=”fontweight: 400;”>” 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 knowhow, trade secrets, clinical data, or financial, administrative, cost, pricing or management information.span>p>