[Ip-health] Army ATI Pfizer contract is the worst yet, as regards patent, data and regulatory rights

James Love jamespackardlove at gmail.com
Wed Nov 18 06:17:33 PST 2020


The OWS people are rapidly publishing more of the contracts, and they are
trying to have fewer redactions.  The Army ATI Pfizer contract is out, and
it is pretty bad.

The USA gets nothing "for inventions conceived or first actually reduced to
practice in the performance of this Statement of Work" AND allows the
company to suppress inventions as trade secrets.   The US government gets
extremely limited data rights, and limited rights to use FDA
communications.

Jamie

https://www.hhs.gov/sites/default/files/pfizer-tdl.pdf

---------------
7.0 INTELLECTUAL PROPERTY, DATA RIGHTS, AND COPYRIGHTS

As set forth more fully in Section 11.7, the provisions of this Section 7.0
supersede and replace, in their entirety, the provisions of Article X
(Patent Rights), Article XI (Data Rights) of the Base Agreement.

7.1 Inventions

As between Pfizer and the Government, Pfizer shall hereby retain all of its
rights, titles and interests in and to any and all inventions conceived and
reduced to practice by Pfizer and/or BioNTech (i) as of the Effective Date
of this Agreement, or (ii) after the Effective Date of this Agreement,
outside the scope of this Statement of Work ("Background Inventions").
Pfizer does not grant to the Government any license to practice the
Background Inventions under this Agreement.

As between Pfizer and the Government, all inventions conceived or first
actually reduced to practice in the performance of this Statement of Work
("Subject Inventions") shall be owned by Pfizer. If invented solely by
Pfizer, Pfizer will be able to elect, in its discretion, whether to hold
Subject Inventions as trade secrets, and holding a Subject Invention as a
trade secret will not forfeit title to the Government. Pfizer does not
grant to the Government a license to practice any Subject Inventions on
behalf of the Government.

Notwithstanding the foregoing, and as set forth more fully in Section
1.1.2, the Government acknowledges that it is not funding the research or
development of the vaccine, or CMC/process development in respect thereof.
As such, neither Pfizer nor the Government anticipate the conception or
reduction to practice of any Subject Inventions.

The Government acknowledges that the Bayh-Dole Act does not apply to or
govern this Agreement. Given that the Government will not fund the
conception or reduction to practice of Background Inventions or Subject
Inventions hereunder, this Agreement shall neither (i) give the Government
any rights to "march-in," as that term is defined in 35 U.S.C. § 203, nor
(ii) subject Pfizer to the manufacturing requirements of 35 U.S.C. § 204.
Page 17

7.2 Data

The Government recognizes that all data relating to the vaccine has been
and will continue to be generated by Pfizer and its collaboration partner,
BioNTech, without the use of Government funding.

As between Pfizer and the Government, Pfizer shall own any and all data
generated by Pfizer and/or BioNTech (i) as of the Effective Date of this
Statement of Work, or (ii) after the Effective Date of this Statement of
Work, outside the scope of this Statement of Work ("Background Data"). As
between Pfizer and the Government, Pfizer also shall own any and all data
generated by Pfizer

---------------
This Statement of Work includes proprietary and confidential commercial
data of Pfizer Inc. that shall not be disclosed outside the MCDC Management
Firm and the Government and shall not be duplicated, used, or disclosed, in
whole or in part, for any purpose other than to evaluate this Statement of
Work and negotiate any subsequent award. If, however, an agreement is
awarded as a result of, or in connection with, the submission of this data,
the MCDC Management Firm and the Government shall have the right to
duplicate, use, or disclose these data to the extent provided in the
resulting agreement. This restriction does not limit the MCDC Management
Firm and the Government's right to use the information contained in these
data if they are obtained from another source without restriction. The data
subject to this restriction are set forth on each page of this Statement of
Work.

US 168054648v17
-------------


page 18

within the scope of this Statement of Work ("Subject Data"). For the
avoidance of doubt, the parties do not anticipate Pfizer generating any
Subject Data using Government funding.

Pfizer hereby grants the Government a non-exclusive license to use any
Background Data and Subject Data contained in the deliverables pursuant to
Section 4, but solely to the extent necessary for the Government to perform
its obligations under this Agreement and arrange administration of the
doses delivered in accordance with FDA and other applicable regulations.

The Government will provide Pfizer with no less than thirty (30) days'
written notice prior to releasing, in response to a Freedom of Information
Act (FOIA) request, any document submitted by Pfizer to Government. During
this 30-day period, Pfizer shall have the right to notify Government which
documents, if any, contain trade secrets of Pfizer, BioNTech or their
respective collaboration partners (or other information legally
withholdable from release under FOIA).



7.3 Regulatory Rights

Pfizer will seek and anticipates that it will achieve FDA-approval or
authorization and commercialization of Pfizer and BioNTech's mRNA-based
Vaccine against SARS-CoV-2 Coronavirus (the "Technology").

Pfizer and the Government agree to the following:

Communications. Pfizer will provide the Government with all formal written
responses from the FDA regarding the Technology [(b) (4)  Redacted]

Pfizer also shall use diligent efforts to provide to the USG Government any
and all FDA inspection and compliance notices, observations, and responses
from Pfizer [(b)(4) redacted] The Government shall limit distribution of
these documents to HHS and DoD regulatory personnel, and may share the
substance of the documents to others within the DoD and HHS that have a
need to know.

DoD Medical Product Priority. PL 115-92 allows the DoD to request, and FDA
to provide, assistance to expedite development of products to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions facing
American military personnel. Pfizer recognizes that only the DoD can
utilize PL 115-92. [Redacted]

Pfizer shall submit Public Law 115-92 Sponsor Letter that will be delivered
to the designated OWS POCs [redacted]

-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


-- 
James Love.   US Mobile is +1.202.361.3040.  Geneva Mobile is
+41.76.413.6584
http://twitter.com/jamie_love, http://keionline.org/jamie


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