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Jennifer Plitsch

Jennifer Plitsch is a member of the Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
  • the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

UPDATED AS OF 10/26/2022:

Changing course after its August 31 announcement that it would not enforce the federal government contractor vaccination mandate absent further written notice, on October 14, 2022, OMB and the Task Force published an update stating that they plan to issue at least three new guidance documents with an eye toward potentially resuming enforcement of the mandate:

  1. First, OMB plans to notify Federal agencies about compliance with applicable injunctions and whether contract clauses implementing the mandate should be included in new solicitations and contracts.
  • Second, the Task Force plans to update its November 2021 workplace safety protocols guidance related to the mandate.  The updated guidance will provide a timeline for any implementation long enough to ensure that covered contractors can come into compliance as needed.
  • Third, OMB will review the safety protocols guidance and make a determination on whether it promotes economy and efficiency in government contracting.  If OMB makes such a determination, it will provide additional guidance to agencies on timing and considerations for providing written notice to contractors regarding enforcement, except as barred by any injunction.

Continue Reading OMB and Safer Federal Workforce Task Force Preview Forthcoming Guidance on Federal Contractor Vaccine Mandate

On August 25, 2022, President Biden announced a new Executive Order (“EO”) addressing the Implementation of the CHIPS Act of 2022 (“CHIPS Act”).  The CHIPS Act was signed by President Biden on August 9, 2022, and, among other things, authorizes $39 billion in funding for new projects to establish semiconductor production facilities within the United States.  The new EO identifies the Administration’s implementation priorities for this CHIPS Act funding and creates the CHIPS Implementation Steering Council to aid with the rollout of administrative guidance.  In connection with the EO, the Department of Commerce launched CHIPS.gov, which is intended to be a centralized resource for potential applicants of CHIPS funding.  The EO and new website reflect the Administration’s intent to swiftly implement the CHIPS Act and increase the domestic production of semiconductors. Continue Reading Biden Administration Announces Priorities for the Implementation of the CHIPS Act of 2022

Earlier this year, the Department of Labor’s Office of Federal Contractor Compliance Programs (“OFCCP”) opened the Contractor Portal, a new platform where covered federal contractors and subcontractors must annually certify whether they are meeting their requirement to develop and maintain written Affirmative Action Programs (“AAPs”).  As we previewed in

Continue Reading OFCCP Contractor Portal:  It’s Not Too Late

Many contractors are familiar with the Davis-Bacon Act (“DBA”), the statute that requires government contractors to pay prevailing wages to workers employed in the construction, alteration, or repair of buildings or other public works.  The DBA is enforced by the Department of Labor, which is responsible for issuing the “wage determinations” that list the prevailing wages for different labor categories within a geographical area and for promulgating regulations used to implement the DBA’s requirements.

On March 18, 2022, the Department issued a notice of proposed rulemaking (“NPRM”), announcing that it intends to make a number of revisions to the DBA regulations.  In the Department’s view, these revisions represent the largest change to the DBA regulations since the last major rewrite in 1981.Continue Reading Department of Labor Proposes Overhaul to Davis-Bacon Act Regulations

Since May 2020, federal efforts to fast-track the development, manufacturing, and distribution of COVID-19 vaccines has been led by a joint effort between the Department of Health and Human Services (“HHS”) and the Department of Defense (“DoD”), formerly known as Operation Warp Speed but renamed the HHS-DoD COVID-19 Countermeasures Acceleration Group (“CAG”).  As of December 31, 2021, the CAG was dissolved, and the entire responsibility for managing the government’s vaccine efforts transitioned to HHS.  On January 19, 2022, the Government Accountability Office (“GAO”) released a report examining that transition, as part of its ongoing obligation under the CARES Act to monitor the federal government’s pandemic response.  The report includes a few key findings and recommendations that will be of interest to industry partners operating within this space.
Continue Reading New GAO Report: HHS Faces Outstanding Issues as it Assumes Vaccine Responsibilities

On December 2, 2021, the Department of Labor’s Office of Federal Contractor Compliance Programs (“OFCCP”) announced the creation of a new Contractor Portal.  Starting next year, federal prime contractors and subcontractors will be required to register on the portal and submit a formal certification, on an annual basis, as to whether they have developed and maintained an Affirmative Action Program (“AAP”) in accordance with OFCCP requirements.  If selected by OFCCP for a compliance review, contractors will use the same portal to upload their AAPs in addition to any other requested information.  The Contractor Portal is expected to open for registrations on February 1, 2022, with the certification features available March 31, 2022.  By June 30, 2022, all existing contractors and subcontractors must certify compliance with the AAP requirements.
Continue Reading OFCCP’s New Contractor Portal: What Contractors Need to Know

Several federal courts have issued preliminary injunctions blocking the Biden Administration from enforcing its federal contractor COVID-19 vaccine mandate.  As discussed in our previous posts, President Biden issued Executive Order 14042 mandating that employees of federal contractors and subcontractors be vaccinated against COVID-19 and take various other workplace safety measures.  Executive Order 14042 relies on the president’s authority under the U.S. Constitution and the Federal Property and Administrative Services Act (“FPASA”) to effectuate this policy.  Prior to issuance of the injunctions, contractors were required to have covered employees fully vaccinated by January 18, 2022.
Continue Reading Contractor COVID-19 Vaccine Mandate Blocked Nationwide – UPDATE

On September 24, the Safer Federal Workforce Task Force released guidance on workplace safety protocols for federal contractors and subcontractors related to COVID-19 (“the Guidance”).  The Guidance was issued pursuant to President Biden’s Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

As expected, the Guidance covers a broad range of contract types and contractors, and mandates COVID-19 vaccinations for covered contractor employees along with masking and social distancing measures to prevent the spread of the disease.  But it also includes some unanticipated exceptions.  The Guidance sets baseline requirements under the Executive Order that are expected to be updated over time and implemented through a contract clause that will be issued by the Federal Acquisition Regulatory (“FAR”) Council.  Federal contractors should carefully examine the Guidance and ensure that they are prepared to timely comply as well as monitor for and adapt to any updates from the Task Force.

Our prior post on the Executive Order can be found here.Continue Reading Task Force Releases Guidance on New COVID-19 Vaccine Mandate for Federal Contractors

On September 9, the Biden Administration released a number of new details for its Path out of the Pandemic that will impact U.S. Government contractors and a number of other individuals and entities.  In addition to requiring most executive agency employees to receive COVID-19 vaccines, the Administration plans to mandate that executive agency contractors and subcontractors, with some exceptions, impose similar requirements on their employees pursuant to an executive order that will fully go into effect on October 15, 2021.  The overall impact of the executive order will not be clear until additional details are released in the coming weeks, but government contractors should begin considering the implications of the new requirements and take steps to ensure timely compliance.
Continue Reading COVID-19 Vaccine Requirements for U.S. Government Contractors

The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk.  These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats.  The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness.
Continue Reading The Next Pandemic: New Bill Looks Ahead to Counteract Novel Threats