Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Novavax, COVID-19 Vaccine Development Agreement

  • Intellectual Property | Ownership of IP

<p><span style=”fontweight: 400;”>“<strong>Specifically Negotiated License Rightsstrong>” means are those rights to Data that have been specifically negotiated between the Government and the MCDC on behalf of the member entity or PAH whose proposal is selected by the Government under a call for proposals issued under the OTA.span>p>
<p><span style=”textdecoration: underline;”><b>SOW: 7.0 Intellectual Property, Data Rights, and Copyrights b>span>p>
<p><b>7.1 Background IP b>p>
<p>(a) <span style=”textdecoration: underline;”>Ownershipspan><span style=”fontweight: 400;”><span style=”textdecoration: underline;”>.span> Prior to June 8, 2020, Novavax had funded the development of NVXCoV2373, and other antecedent vaccine programs relevant to Novavaxproprietary position in the development of NVXCoV2373, as well as its sf9/baculovirus manufacturing platform, (allspan><b><i>Background IPi>b><span style=”fontweight: 400;”>”) through private funding or in collaboration with a funding partner other than the U.S. Government. Such private and nongovernmental funding has continued since June 8, 2020 and is expected to continue during the performance of the Project Agreement. A list of all patents and patent applications included in the Background IP is provided below as Enclosure 4. Background IP also consists of (a) manufacturing knowhow, including, without limitation, the NVAXCov2373 manufacturing process definitions, process development/characterization reports, laboratory scale process procedures, manufacturing records, analytical test methods, product quality target ranges/specifications, quality target product profile, critical quality attributes (collectivelyspan><b><i>Background Know-Howi>b><span style=”fontweight: 400;”>”), (b) data from preclinical and clinical research studies, analytical and process development research, and data related to, or generated using, the Background Know-How (collectively, “span><b><i>Background Datai>b><span style=”fontweight: 400;”>”), and (c) proprietary manufacturing materials, including, without limitation, sf9 cell banks (master and working), baculovirus virus stock (master and working), product standards, reference standards, and critical reagents (“span><b><i>Background Materialsi>b><span style=”fontweight: 400;”>”). On June 8, 2020, Novavax and the U.S. Department of Defense entered into a Letter Contract for specified U.S.-based clinical and manufacturing development of NVXCoV2373 which acknowledged Background IP and made no explicit U.S. Government claims to Background IP or subsequent data arising therefrom. The U.S. Government hereby acknowledges such Background IP in full and further acknowledges that it has no ownership rights to Novavax Background IP under this Project Agreement.span>p>
<p><b>7.2 Foreground IP b>p>
<p><span style=”textdecoration: underline;”>(a) Ownership.span> Notwithstanding anything in the Base Agreement to the contrary, Novavax owns all rights, title and interest in and to any development, modification, discovery, invention or improvement, whether or not patentable, conceived, made, reduced to practice, or created in connection with activities funded under the Project Agreement, including, without limitation, all data and inventions, and intellectual property rights in any of the foregoing (“<b><i>Foreground IPi>b>”).p>
<p><span style=”textdecoration: underline;”><strong>Statement of Work: 8.0 Data Rightsstrong>span>p>
<p><span style=”textdecoration: underline;”><a href=”” target=”_blankrel=”noopener“>Article XI, §11.03a>spanof the Base Agreement is hereby amended, consistent with theSpecifically Negotiated License Rightscapability at Article XI, §§11.01(12) and 11.03(4), as follows:p>
<p><b>8.1 Data Ownershipb>p>
<p><span style=”fontweight: 400;”>Novavax owns all rights, title and interest to all Data (as defined in Article XI, Section 11.01(7) of the Base Agreement) generated as a result of the work performed under this Project Agreement, including Subject Data.span>p>
<p><b>8.3 Background Technical Data Rights Assertionsb>p>
<p><span style=”fontweight: 400;”>Novavax asserts background technical data rights as follows: The Background Data, as defined in Section 7.1 above, was developed through private funding or in collaboration with a funding partner other than the U.S. Government. Such funding is expected to continue; accordingly, Novavax asserts Background Data as Category A Data pursuant to section 11.02(1) of the Base Agreement and the U.S. Government shall have no rights therein.span>p>