Alexander Hastings

Alexander Hastings

Alex Hastings advises clients across a broad range of government contracting issues, including advising clients in transactional matters involving government contractors and assisting defense contractors and pharmaceutical companies in securing and performing government contracts.

Mr. Hastings also advises clients concerning best practices in e-discovery. He assists in investigations and litigations that involve complex e-discovery issues and has represented clients in matters involving the U.S. Department of Justice, Securities and Exchange Commission and the United States International Trade Commission.

Mr. Hastings’ government contracts experience includes advising clients regarding new developments in regulatory requirements, including the Federal Acquisition Regulation’s (FAR) anti-human trafficking requirements and the FAR and Bayh-Dole Act’s intellectual property provisions. Mr. Hastings also provides due diligence regulatory advice to clients contemplating the acquisition of government contracting entities or assets.

Mr. Hastings’ e-discovery experience includes advising a wide-array of clients on best practices in information governance and document collection and assisting clients develop effective mobile device and document management policies.

Mr. Hastings also maintains an active pro bono practice and routinely writes on issues related to government contracts and e-discovery.

 

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Trump Administration Increases Uncertainty for Pharmaceutical Manufacturing

Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”).  The Order sets forth an ambitious plan requiring extensive agency action on a … Continue Reading

U.S. Government Seeks Industry Solutions in Novel Coronavirus Response

As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than … Continue Reading

Trump Administration Renews Focus on Anti-Human Trafficking Efforts

The Trump Administration has declared this month National Slavery and Human Trafficking Prevention Month, calling on industry associations, law enforcement, private businesses, and others to work toward ending modern slavery and human trafficking. This proclamation follows the Administration’s efforts to combat human trafficking, which we have previously discussed here, and comes on the heels of … Continue Reading

Momentum In Drug Pricing Reform: House Passes New Legislation on the Heels of Presidential Candidates’ Drug Pricing Proposals

Late last week, House Democrats passed Speaker Nancy Pelosi’s Elijah E. Cummings Lower Drug Costs Now Act. This bill would, among other things, permit the Department of Health and Human Services (“HHS”) to negotiate lower prices for 250 of the costliest drugs on behalf of Medicare beneficiaries and other consumers. Although this particular legislation appears … Continue Reading

How Much Is Enough? Federal Circuit Appeal May Decide Level of U.S. Manufacturing Required Under the TAA

A long-standing dispute over the approach to country of origin determinations under the Trade Agreements Act (“TAA”) may soon be resolved, as the Federal Circuit recently heard oral argument in one of two cases presently examining key aspects of this statute.  Among other questions presented, the court may decide the standard for determining whether a … Continue Reading

Rights in Government-Funded IP: Changes May be on the Horizon

Many entities engaged in federally funded R&D have closely monitored the efforts of the National Institute of Standards and Technology (“NIST”) over the last year as it has studied strategies for maximizing U.S. innovation through government-funded research.  Last week, NIST published its findings in NIST Special Publication 1234, Return on Investment Initiative for Unleashing American … Continue Reading

More Novation Complexity In Gov’t Contracts M&A?

(This article was originally published in Law360 and has been modified for this blog.) Government contractors undergoing an asset transaction know all too well the peculiarity and uncertainty associated with the transfer of a U.S. government contract through the required novation process. In two recent decisions, the Government Accountability Office considered the impact of such … Continue Reading

4 Considerations For Gov’t Contractor Carveout Deals

[This article was originally published in Law360.] A steady flow of M&A activity in the government contracts industry continues. Indeed, last year we saw over 100 publicly reported deals involving government contractors, and this pace has continued into 2018. This M&A activity has taken a variety of forms, including a number of “carveout” transactions, where … Continue Reading

Fraudulent SAM Accounts Lead to More Complicated SAM Registration Requirements

GSA recently announced it is supporting an Inspector General investigation into alleged, third-party fraudulent activity in the System for Award Management (“SAM”). The GSA announcement suggests that fraudulent SAM accounts may have been used to divert certain federal payments to unauthorized bank accounts. The announcement does not elaborate on the scope of potentially impacted entities … Continue Reading

The Long-Standing TAA “Substantial Transformation” Standard for Drug Products is Challenged at the Court of International Trade

A generic pharmaceutical distributor, Acetris Health, LLC, has challenged the Final Determination of U.S. Customs and Border Protection (“Customs”) that Acetris’ generic prescription drug, Rosuvastatin Calcium Tablets (“Rosuvastatin”), is a product of India, the place where the active pharmaceutical ingredient (“API”) is produced.  If successful, the challenge in the U.S. Court of International Trade (“CIT”) … Continue Reading

California Law Aims to Scrutinize Drug Pricing

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state … Continue Reading

Protecting Intellectual Property as Government R&D Funding Rises

The U.S. Government’s research and development (“R&D”) spending is on the rise.  For instance, the U.S. Government spent $139 billion in on R&D in FY 2015 and approximately $148 billion in FY 2016.  It is slated to spend as much as $154 billion on R&D in FY 2017.  With this funding comes great opportunities for … Continue Reading

Senate Committee Directs DoD to Reduce Drug Prices

In its Report on the National Defense Authorization Act for Fiscal Year 2018, the Senate Armed Services Committee (the “Committee”) included an “Item of Special Interest” directing the DoD to exercise its rights under the Bayh-Dole Act “to authorize third parties to use inventions that benefited from DOD funding whenever the price of a drug, … Continue Reading

Department of State Releases 2017 TIP Report

The Department of State has released its 2017 Trafficking in Persons (“TIP”) Report.  As with prior versions of the annual report, the State Department reviewed efforts made by more than 180 countries to address the minimum Prosecutorial, Protective, and Preventative standards necessary for effective anti-trafficking measures, as these standards are outlined in the United States’ … Continue Reading

Section 809 Panel Urges Congress to Bring DoD Spending into the 21st Century

The Section 809 Panel recently released an interim report and supplement (the “Interim Report”) advocating in broad strokes for a host of improvements to the Department of Defense’s (“DoD”) acquisition system to better streamline the process and increase industry offerings to the government.  The NDAA for FY 2016 established the Section 809 Panel to address … Continue Reading

Trump’s Commitment Against Human Trafficking Brings Greater Uncertainty for Contractors

Last Thursday, President Trump and his senior advisors met with representatives of organizations committed to fighting human trafficking. As reported by several news outlets (e.g., AP, NYT, and Reuters), the President stated during the meeting that he would commit the “full force and weight” of the U.S. government against what he views as an “epidemic” of … Continue Reading

New Guidance on Contractor Risk Management Under the Human Trafficking Rule Released

On December 7, the Office of Management and Budget, the Department of Labor, and the Office to Monitor and Combat Trafficking in Persons in the Department of State, issued a proposed memorandum titled “Anti-Trafficking Risk Management Best Practices & Mitigation Considerations.”  The document is intended, at least in part, to “promote clarity and consistency in … Continue Reading

The GAO Is Not Down With OFCCP: Report Criticizes Agency’s “Weak” Compliance Evaluations and May Trigger Increased Contractor Oversight

The Government Accountability Office (“GAO”) recently released a study of the Office of Federal Contract Compliance Program’s (“OFCCP” or the “Agency”) oversight functions for fiscal years 2010 to 2015.  GAO’s report explains that “OFCCP has not found violations in the vast majority of its compliance evaluations,” noting that in the time period GAO studied, OFCCP … Continue Reading

Changes to Small Business Subcontracting On the Horizon

Last week, the Federal Acquisition Regulation (“FAR”) Council issued a Final Rule to implement regulations adopted by the Small Business Administration in 2013.  The Final Rule significantly amends FAR Parts 19 and 52 by imposing additional small business-related obligations on prime contractors and clarifying the consequences of failing to satisfy those obligations.  The Final Rule … Continue Reading

Supreme Court on False Claims Act: Implied Certification OK, But Materiality Is No Gimme

Last week, in Universal Health Services Inc. v. U.S. ex rel. Escobar, the Supreme Court unanimously affirmed the viability of the “implied false certification” theory of False Claims Act liability, at least in certain circumstances.  Writing for a unanimous Court, Justice Thomas explained that a defendant can face FCA liability under an implied certification theory … Continue Reading

Sample Human Trafficking Compliance Plan Finally Released

This week, the Department of State (“State”), Verité, and other global NGOs, unveiled a sample human trafficking compliance plan and online resource to help contractors comply with the FAR’s anti-human trafficking rule (the “Rule”).  As we have previously summarized, the Rule requires contractors to implement a compliance plan for contracts exceeding $500,000 that are for … Continue Reading

Proposed Definition of “Recruitment Fees” Published

DoD, GSA, and NASA published a definition of “recruitment fees” for purposes of FAR 52.222-50 in today’s Federal Register.  As we have previously discussed, the anti-trafficking requirements in FAR 52.222-50 were amended almost a year and a half ago to prohibit contractors from charging employees recruitment fees, without defining such fees.  Subsequent efforts to define … Continue Reading

Human Trafficking Model Compliance Plan and Internet-Based Compliance Tools Set for Release this Month

The Department of State (“State”) recently announced the upcoming release of the model anti-human trafficking compliance plan. State and Verité, a global NGO, developed this highly-anticipated model compliance plan in response to the amendments to FAR 52.222-50, which require contractors to perform supply chain due diligence and implement a compliance plan for contracts exceeding $500,000 … Continue Reading

Non-TAA-Compliant Covered Drugs Must be Offered to the VA in the Coming Weeks

The United States Department of Veterans Affairs (“VA”) recently announced a significant change in policy that will allow it to purchase drug products that were previously unavailable due to the Trade Agreements Act (“TAA”) because they were manufactured in countries with whom the United States does not have a procurement agreement in place.  The VA … Continue Reading
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