In an earlier post, we explored some of the key issues in a contract manufacturing agreement from the perspective of the drug developer. However, Outside GC frequently represents outsourced manufacturers, too. The knowledge we’ve gained from working on both sides of the table enables us to effectively and efficiently negotiate agreements that satisfy both parties.
As a start-up tech company, you’ve likely poured hundreds of hours into the development and testing of a marketable product, and have pitched your idea to countless investor groups and prospective customers. After your product is launched and customers are being signed up, a whole new set of concerns will present themselves. For start-ups targeting customers in the healthcare industry, these concerns will likely include the adoption of critical compliance and risk mitigation protocols mandated by HIPAA for the so-called “Business Associates” of “Covered Entities.”
Nonprofit legal departments can expect changes in 2019 due to new federal and state laws passed last year. Lakshmi Sarma Ramani, a member with our Washington D.C.-based team, offers an overview of the key issues that may impact nonprofits in her latest ACC Docket article.
New H-1B visa petitions (including change of status petitions) can be filed with the U.S. Citizenship & Immigration Services (“USCIS”) beginning April 1, 2019 for an effective start date of October 1, 2019. H-1B petitions are accepted on a "first-come-first-serve" basis, and the demand for H-1B visas is expected to be very high again this year. We therefore plan to file all cap-subject Petitions for USCIS receipt on April 1, 2019.
In the wake of an historic, multi-state lawsuit filed against a “Business Associate” earlier this month, it is imperative that companies with business associate agreements (BAA) in place with health care/plan customers review internal data security policies and procedures to ensure they are in compliance with their obligations arising under HIPAA, state privacy laws and the BAAs.
Outside GC Member Stephan Grynwajc continues to keep a close eye on the fate of the EU-U.S. Privacy Shield data-sharing arrangement.
In this timely ACC Docket piece, Lakshmi Sarma Ramani (Washington D.C.-area team) reviews the IRS rules related to general lobbying and political campaign activity which apply to tax-exempt organizations.
"I think one of the best indicators of career satisfaction for an on-demand GC is that, like me, many lawyers choose this role at the pinnacle of their in-house careers. I am able to continue pursuing a professionally challenging career, while maintaining control over my time and my life," explains Outside GC Member, Lakshmi Sarma Ramani, in her recent article published in the ACC Docket's July/August issue.
