COVID-19

[anonymous]

7 COVID-19 updates from the FDA
The FDA has implemented several measures to curb the COVID-19 pandemic and ease the burden on health systems across the country.

Seven updates:

Editor's note: This is not an exhaustive list. Updates are listed in order of most recent to least.

1. FDA is allowing providers to skip some protocols so they can give patients access to drugs while remaining self-isolated or quarantined. Some drugs require patients to undergo risk evaluation and mitigation strategy tests, or REMS, which are lab tests or imaging requirements, before they are given access to the treatments. For drugs subject to REMS, healthcare providers prescribing and dispensing these drugs should consider whether there are compelling reasons not to complete the tests during the COVID-19 pandemic. The FDA advised providers to use their "best medical judgment" in weighing the benefits and risks of continuing to provide drugs without lab tests or imaging studies.
   
   
2. FDA is allowing hospitals to repurpose existing machines as ventilators. As hospitals face a critical shortage of ventilators, the FDA said it is being flexible in speeding up the regulatory process for acquiring the devices. Hospitals will also be allowed to use ventilators typically used for other environments in hospital settings, such as a ventilator normally used in an ambulance. The agency suggests hospitals look into other devices that may help patients, such as continuous positive airway pressure, or CPAP, devices typically used to treat sleep apnea.
   
   
3. FDA authorized COVID-19 diagnostic tests that can give results within hours, rather than days. The tests are point-of-care tests, meaning they can produce results at hospitals rather than having to be sent to an outside laboratory. They are made by a molecular diagnostics company called Cepheid, and the company plans to roll them out by March 30.
   
   
4. FDA warns the public of fake COVID-19 tests marketed to be used by consumers at home. The agency said it hasn't approved any at-home COVID-19 tests and that fake tests could pose serious health risks, including keeping some people from seeking necessary medical treatment if the result is inaccurate.
   
   
5. FDA said it won't punish temporary manufacturers of alcohol-based hand sanitizer to deal with supply shortages. It outlined steps manufacturers will have to take to make unregulated hand sanitizer, including having to find a way to submit any potential adverse events reports related to the hand sanitizer to the FDA.
   
   
6. FDA expanded use of some vital sign-measuring devices to allow providers to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. The goal is to reduce the number of people who come into the hospital and minimize potential coronavirus exposure.
   
   
7. FDA is urging the public to donate blood to help offset shortages during the COVID-19 pandemic. The agency said the number of donations has been dramatically reduced because of social distancing and canceled blood drives, but it said coming to blood donation centers is safe.

 

[anonymous]

Among Covid-19 vaccine technologies, mRNA represents faster, easier approach, some experts say

There are multiple platforms for developing vaccines against the SARS-CoV-2 virus, including messenger RNA, DNA and molecular clamp. Moderna said last week that it had dosed the first patient in its Phase I mRNA vaccine trial.

By ALARIC DEARMENT

Last week, a potential ray of light pierced the darkness enveloping the world amid the novel coronavirus’ seemingly relentless spread. That’s when a Cambridge, Massachusetts-based biotech company announced it had dosed the first volunteer in the Phase I study of its investigational vaccine against the virus, known as SARS-CoV-2.

It remains to be seen whether the National Institutes of Health-led study of Moderna’s mRNA-1273 will prove the vaccine safe and effective. Moderna is one of several companies developing vaccines against the virus, which since its emergence in December in the central Chinese city of Wuhan has infected more than 360,000 worldwide as of Monday and killed more than 15,000. Minute by minute increases of cases can be tracked here.

But the hard reality is that it could be a year or longer before a vaccine actually reaches the market. In fact, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said at a recent press conference that the Moderna study would take 12 months. MedCity News interviewed experts who pointed to a number of factors to consider as vaccine candidates move through the clinic, including biological elements that could make or break them.

The process of developing vaccines has evolved considerably, not only since the days of Louis Pasteur, but even from 20-30 years ago, said Dr. Shan Lu, professor of medicine, the University of Massachusetts, in a phone interview. “The process is getting longer and more complicated, but this is not just unique to this coronavirus.”

In a paper published earlier this month in the journal Emerging Microbes & Infections, Lu noted that the 2002-2003 SARS outbreak and the more recent Zika virus outbreak also prompted calls for vaccines. Those calls faded after those viruses peaked due to falling public demand and those viruses never achieved pandemic status. Nevertheless, timely development of vaccines against SARS-CoV-2 is needed to control the infection, bring the economy back on track and “stabilize the global mood.”

The ClinicalTrials.gov lists four trials of Covid-19 vaccines, including Moderna’s and three taking place in China, including a Phase I sponsored by CanSino Biologics and two trials – a Phase I and a Phase I/II – at the Shenzhen Geno-Immune Medical Institute.

There is a lot more research happening and ideas floating around today than there was during the SARS epidemic, when there were fewer biotechnology companies and research labs, Lu added.

“I am still shocked every day to read about some new company I’ve never heard about,” he said.

In addition to Moderna, other firms, both large and small, are developing vaccines of their own, including French drugmaker Sanofi – under a partnership with the Department of Health and Human Services – and Strand Therapeutics, a private company also based in Cambridge.

In the journal paper, Lu highlighted the Coalition for Epidemic Preparedness Innovations’ January announcement that it would fund three platform vaccine technologies for SARS-CoV-2, namely DNA, messenger RNA (mRNA) and molecular clamp. Moderna, as the name of its product candidate suggests, uses an mRNA approach. Sanofi, by contrast, is using a recombinant DNA platform that was developed using a means similar to its recombinant influenza vaccine. The company said in the same announcement that it had a “head start” thanks to the previous efforts to develop a vaccine against SARS by Protein Sciences, a firm it acquired in 2017.

Of the different approaches, mRNA holds the most promise, Strand CEO Jake Becraft said in a phone interview. While acknowledging a bias in favor of mRNA given that it’s the approach his company mostly works on, Becraft said he favors it because it seemed more promising when he got into the field.

“The general idea of delivering a synthetic gene is that you need to get it into the area of a cell that will cause that gene to be made into a protein,” Becraft said. That occurs in two steps: Transcription, whereby DNA is converted into RNA, and translation, where RNA is converted into protein. Transcription happens inside the nucleus of a cell, whereas translation happens in the cytoplasm. Because the nucleus exists to protect the DNA, it’s a highly guarded region, making it difficult to penetrate. By contrast, the cytoplasm is much easier to penetrate, hence the interest in mRNA.

“You can get a much higher rate of delivery with a lesser amount of material,” Becraft said. In other words, if the ratio of dosage to actual delivery into cells is 10% for DNA vaccine, it’s more like 20% for an mRNA vaccine, meaning an mRNA vaccine would have lower dosing requirements and also be faster to manufacture in large quantities.

The mRNA approach also cuts down the development time.

“The fastest way to a vaccine these days is with an RNA vaccine,” said Dr. Warner Greene, professor of medicine at the University of California San Francisco, not affiliated with Strand, in a phone interview. “You can get into the clinic faster.”

Still, because SARS-CoV-2 is an RNA virus, it presents a challenge in its potential ability to mutate around vaccines that may target one specific point and thus become resistant. For the time being, that doesn’t appear to be happening, Greene said, noting that its genetic sequence has stayed pretty constant among isolates from China, South Korea and so forth. That’s because it has a “proofreader enzyme,” making it much less prone to mistakes as it replicates and less mutable than HIV or hepatitis C.

“By and large, it’s the same coronavirus – it’s not rapidly mutated,” Greene said. But that doesn’t mean that won’t happen. “We as a human species are not putting immune pressure on it” due to our lack of natural immunity.

Given the larger number of groups working on vaccines, one potential risk is that it could lead to the field could become too crowded, Lu said, using the analogy of a battlefield with too many soldiers and weapons. In other words, a larger number of companies working on vaccines, along with new and competing technologies and regulatory processes could actually make the development of a SARS-CoV-2 vaccine go slower rather than faster.

Lu’s paper pointed to enhanced safety concerns, more complicated manufacturing processes and related assay requirements that were adding to the time and cost for new vaccine development.

But Greene didn’t think that would be the case and made a comparison with the case of HIV drugs, where there had been early approval of new medicines by the FDA. “I think there will be a streamlined approach,” he said. “I don’t think they will wind up being the obstruction – if they are, it will be a real problem, kind of like the lines at Chicago O’Hare [International Airport].”

 

[anonymous]

When might experimental drugs to treat Covid-19 be ready? A forecast

There is a desperate need for new medicines to treat Covid-19, the disease caused by the novel coronavirus that has shut down much of the world. A vaccine to prevent infection entirely would be even better.

Drug companies and medical researchers are making heroic efforts to deliver new medicines. Several dozen are now in development, and you can see highlights of those efforts here. Studies so far are mostly small and lack real control groups, making it hard for researchers to be sure of their conclusions.

Doctors on the front lines have been trying older medicines, such as the malaria drugs hydroxychloroquine and chloroquine, in the hopes that they will prove effective. Large studies of such medicines are already in process.

But the relentless pace of the virus’ spread and a sense of desperation can only do so much to speed up the development of new medicines. Normally, the process to develop new medicines can take a decade or more. And many experimental medicines fail. When it comes to infectious disease treatments, data from the Biotechnology Innovation Organization put the success rate of new medicines just starting clinical testing at 1 in 5.

Is there hope that something will be available soon to help us fight this virus, known as SARS-CoV-2? Here’s a look at what’s on tap and how soon it could be ready. For almost any treatment or preventative, supply could be an issue if large numbers of people need it. Lastly, please note: Some of these timelines could shift, and some of these treatments and vaccines are likely to fail. That is the unfortunate reality of how medicine works.

An existing, easy-to-produce medicine that proved effective at treating or preventing SARS-CoV-2 infection would provide the fastest relief for patients and doctors. The early hope is on hydroxychloroquine and chloroquine, and many hospitals, including the University of California, San Francisco, and the University of Washington, include them in their treatment guidelines. Some doctors are combining hydroxychloroquine with azithromycin, an antibiotic. Much of the published evidence comes from a very small French study and reports from China. Larger, more rigorous clinical trials are starting, but they will take time. Favipiravir, a flu drug shown in Japan, appeared beneficial in another small study. These medicines, especially the malaria drugs, which are being mass-produced, will be used by doctors on the front lines, but we will have to wait for evidence of whether they are benefitting patients and how much.

 

[anonymous]

Remdesivir
Timeline: First data could come in April

Remdesivir, an antiviral medicine that failed as an Ebola treatment, was initially developed to work against a different coronavirus. There’s some evidence that it benefits Covid-19 patients. Its maker, Gilead, has been working with researchers and governments around the world to get clinical trials up and running. The company has said to expect results in April. Six large studies are in progress, with the first, in severely ill patients in China, due to finish as early as April 3, according to a government website. A study in patients with milder disease will also finish in April, with two more due in May. In the meantime, Gilead has made the drug available to hundreds of patients on a compassionate use basis. However, it recently said that, due to overwhelming demand, it would suspend access to the drug for all but pregnant women and children as it works to create a more systematic way of giving it out without interfering with clinical trials. This new system should be in place soon. Remdesivir must be given intravenously.

Convalescent plasma
Timeline: May see some use immediately, but research could take months

It’s an old idea that has proven effective in other epidemics: give patients who are sick blood plasma from those who have recovered. It can work because the plasma contains antibodies against the virus, weaponizing the immune system of the sick patient.

One recent study from China reported that of 10 patients given convalescent plasma, seven saw their viral loads become undetectable; it noted other improvements in their condition.

Takeda is developing a more refined version of this approach that uses more concentrated antibodies taken from blood. Julie Kim, the president of the company’s blood products division, said last Wednesday on a conference call with reporters organized by PhRMA, the trade group, that the product may be available in nine to 18 months.

Arthritis drugs
Timeline: Data could be available by summer; drugs available now

Drugs against autoimmune diseases like rheumatoid arthritis work by tamping down the immune system. This could, ironically, be useful against in Covid-19, because the SARS-CoV-2 virus can make the body overreact, causing what’s called a “cytokine storm,” damaging the body.

Actemra, one such drug made by Roche, is approved for treating the cytokine storm when it is caused by cancer treatments. An unpublished 21-patient study in China showed Actemra reduced fevers and need for supplemental oxygen. Two other firms, Regeneron and Sanofi, launched a study of their similar drug, Kevzara, in Covid-19 patients; the pair has said results on fevers and oxygen use could be available as early as April. Roche has begun its own study of Actemra in the U.S. Both Actemra and Kevzara are artificial antibodies that target a protein involved in the immune system called IL-6, and are given by injection.

Artificial antibodies against the virus
Timeline: Potentially early fall

Many of the pharmaceutical industry’s best-sellers are what are called monoclonal antibodies, which are antibodies developed in mice and then made into drugs that can be injected into patients.

A manufactured antibody, or a mix of manufactured antibodies, might have a more consistent impact than using blood plasma, and it can be off-the-shelf. Regeneron, the Tarrytown, N.Y., biotech, had success developing a mixture of antibodies against Ebola; it is now selecting two to use against SARS-CoV-2, with the expectation that trials could start by early summer. If all goes well, it could be available by early fall for some uses, like treating extremely sick patients. Eli Lilly, working with a Vancouver startup called AbCellera, has said it hopes to start trials of a similar approach within four months. Vir Biotechnology and Biogen are following a similar path. Antibodies might also be used to prevent infection, but that could take longer to test in studies.

New antivirals
Timeline: 2021 at the earliest

If existing antivirals cannot control SARS-CoV-2, brand new medicines may be needed. But this process is at square one, and even moving at full-speed could eat up months. Efforts are underway to search chemical libraries for medicines that could prove effective by the Bill and Melinda Gates Foundation and others. If they can find medicines that have gone through some previous testing, as remdesivir has, that could hasten the process.

Vaccines
Timeline: Late 2021, possibly many years

There is one approach that could deliver a vaccine faster than others: It uses messenger RNA to make cells produce proteins that could lead to immunity. This approach has never been used in a widely available vaccine. The biotech Moderna is in the lead here, but others, such as BioNTech, working with Pfizer, are working on a similar approach.

It could take 18 months to be sure that approach works and is broadly safe. Even with increased manufacturing capacity, supply could be a problem. Other approaches are being developed in tandem, including one from Sanofi, now used for flu vaccines, that manufactures vaccines in insect cells. However, Moderna said in a filing with the SEC Monday that its vaccine might be available for some groups, including health care workers, as early as fall 2020.

“If you look across the many programs that have been launched, if you look at history, not all of those programs will be successful,” said Rajeev Venkayya, president of Takeda’s global vaccines unit, during a press conference last week. “And I think that is something that I don’t think we’ve effectively communicated to the public. Just because we start a vaccine program doesn’t mean that we will definitely get a vaccine on the other end.”

The good news about having so many efforts in progress, he said, is it increases the chances that one will succeed.

 

[anonymous]

COVID-19 Employment and Whistleblower Issues - Interview With an Employment Attorney

We recently spoke with attorney Michael Filoromo about some of the issues surrounding the government's COVID-19 response. These issues included employee rights under the Families First Coronavirus Response Act (FFCRA) and the potential for fraud related to funds provided to companies as part of the government's repsonse.

Michael is a partner with the whistleblower and employment law firm Katz, Marshall & Banks, LLP, in Philadelphia. He has helped achieve successful outcomes for numerous clients under the Sarbanes-Oxley corporate whistleblower protections, the False Claims Act and the anti-discrimination and retaliation protections of Title VII of the Civil Rights Act and corresponding state laws. He regularly represents whistleblowers in the pharmaceutical, healthcare, nuclear, railroad and aviation industries. Mr. Filoromo is the secretary of the Eastern Pennsylvania chapter of the National Employment Lawyers Association. He can be reached at filoromo@kmblegal.com.

CP: What steps should an employee take if they are denied leave or harassed or let go when taking paid time off related to the COVID-19 crisis (relevant to the FFCRA)?

Michael: One thing that is important to know is that the starting assumption in the US is that you are not entitled to paid sick leave. The FFCRA was passed to provide some amount of paid leave in very specific circumstances. So the background is that you can get up to 80 hours of fully paid leave if you are quarantined and have to stay home - essentially the two weeks you are supposed to stay home if you are exposed or show symptoms of the virus.

You can also receive 80 hours at two-thirds of your pay if you are caring for an individual who is quarantined or if you are providing child care if schools are closed. You can also get an additional 10 weeks of pay at two-thirds of your normal rate to care for a child whose school or daycare is closed.

To qualify for any of those forms of leave, you have to have been employed for at least 30 calendar days prior to the first day of leave. One problem is that the FFCRA sick leave provisions only apply to companies with fewer than 500 employees. So a lot of Cafepharma readers who work for larger pharma/biotech companies may not be entitled to that leave at all.

But if you are qualified and you are quarantined, or if your child’s school or daycare is closed, you should be entitled to that paid leave under the FFCRA. This is essentially an amendment to the Family and Medical Leave Act (FMLA). The FMLA provides employment protection for people to take care of their own serious medical condition or to take care of a family member.

The FMLA provides up to 12 weeks of leave but that leave is unpaid by default. It protects someone’s position, but it does not provide any compensation. If you were denied leave that you are entitled to under the FFCRA, your recourse is the same as it would be under the FMLA - a lawsuit.

The FMLA does apply to larger companies, but it does have some holes in it as well. For example what if an employee is in a high-risk group and is concerned about contracting COVID-19, but they don’t actually have it? The FMLA likely would not apply, nor would the FFCRA. Even if it seems like one or both protections should be available to an employee, they may fall into one of the gaps in the laws’ coverage.

So I think that if you are in a position where you are being denied leave or protections you should have it is worth it to consult an attorney, because it is sort of a patchwork of potential protections. Speaking with an employment lawyer can help piece these things together to determine what are the employee’s rights and what are their obligations. It is not clear in many cases and it can be quite complicated. So it makes sense to reach out to an employment attorney to really understand your situation.

CP: Anything in terms of documentation people should keep in mind in reference to a situation where they are being denied leave?

Michael: in general, whenever you do something like requesting leave or blowing the whistle, it is important to do that in writing and get the company to state its position in writing. Usually this is done through a manager or through HR. Once you have the company’s position clarified, you can deal with it and decide best how to proceed, with legal advice if necessary. But you want to make clear that you have made a request and that you understand the response.

CP: Switching gears a little and considering the possibility that there may be an increase in fraud related to the CARES Act funds and possibly the False Claims Act, what types of fraud might be most likely to occur?

Michael: Any time there is a huge infusion of money into the private sector, the risk of fraud is high. This is the largest stimulus package in history. Oversight and regulation is difficult even in a normal environment. This is particularly true in the pharmaceutical industry where there are millions and millions of claims being made via government healthcare programs. In the context of COVID-19 and CARES, oversight will be even more difficult.

When money is suddenly injected into the economy during a crisis with the idea that it will be used for a particular purpose, there aren’t the same structural checks and oversight mechanisms that are in place through CMS and established government healthcare programs. The Department of Justice has already made clear that COVID-19 fraud is going to be a major focus just like it was after the 2008 crisis and after Katrina. Here the crisis is about health.

So you might see manufacturers selling materially substandard or faulty devices that are in high demand - perhaps faulty personal protective equipment or ventilators - or companies misrepresenting the efficacy of certain treatments. Another area where you might see fraud is around the development of vaccines to treat COVID-19. The first company to market with an effective vaccine will be providing a huge service to humanity, but it is also an opportunity to make a huge amount of money. So you can understand a temptation to overstate the efficacy of a vaccine or treatment or do. There will also be a temptation to downplay adverse events and risks, or to make results seem more conclusive than they are.

There are also more technical areas of False Claims Act violations, such as not complying with conditions related to repayment of advanced funds, or not using the funds for their intended purpose. If money is earmarked for a particular thing, to avoid having to repay that money you have to take certain steps and use it appropriately. This won’t always give rise to FCA claims but it is the kind of thing to look for and the type of thing we may see more frequently.

CP: What signs should an employee look for that would indicate that fraud is taking place?

Michael: I think that fudging data and downplaying risks are things reps might see or learn about from people with firsthand knowledge. If you are told to talk up some aspect of a treatment, or the use of a drug for the off-label treatment of COVID-19, that might be something that could indicate wrongdoing behind the scenes. The reality is that you expect development to be accelerated right now, and it would be a great thing for society to develop effective treatments or discover new uses for an existing treatment. But where there is a massive financial incentive, there is the risk of cutting corners, with potentially dangerous results.

You still have to respect the integrity of data even when there is a tremendous societal need, and if you are seeing or hearing that something is being covered up, or maybe something is not being accurately reported to CMS, those are the types of things to look for.

Also, if you have insight into money a company has received to work on some specific issue and you find the funds are being used for something else, that would be a form of fraud.

If an employee suspects fraud, what initial steps should they take? I assume that seeking legal counsel would be an important step, anything else they should do?

One of the first steps is to ask questions and document the concerns that you have. Be specific and identify the questions or concerns that you have. The response may indicate that the issues are innocuous. There may be good explanations. Or the response may sound like something is being covered up or misrepresented.

 

[anonymous]

One of the key reasons to document things is to create a record that allows you to show that you expressed these concerns, and here was the company’s response. It is an escalation beyond having just an informal conversation, and that can be an uncomfortable and possibly risky thing. But it also can provide you with anti-retaliation protections. The False Claims Act, for example, has a provision to provide protection for reporting or attempting to stop fraud, a lot of state laws also prohibit retaliation for reporting misconduct. So both for the sake of being specific and clarifying concerns you have and to provide some protection for employment, documenting concerns is important.

Also, identifying evidence is important so you can say either to the employer or down the road, if you were going to report something to a regulator, here is the evidence for what it is you suspect. Another thing to keep in mind is that reviewing--and especially gathering--evidence can be a perilous thing. You need to take care that in reviewing or gathering evidence, you do so legally, and for that reason, it is better to consult a whistleblower attorney early on. A lot of times people wait until they have been fired or things have spiraled before they consult an attorney. I think an early consultation helps focus the issue and provide guidance and protection for the employee.

I realize that consulting an attorney can feel like a precipitous step, but merely consulting a whistleblower attorney for advice is not the same as launching into full-blown litigation. Just seeking advice from someone who is knowledgeable in the field can help you navigate a difficult situation.

CP: Going back to the discussion about employment issues - since companies may lay off employees during the crisis, what should employees do if they lose their jobs? For example should they sign termination agreements, should they always have agreements reviewed by counsel, and what would legal review of an agreement likely cost for a sales rep level employee?

Michael: Before signing a separation agreement I think it is always a good idea to have an attorney take a look at it. These agreements are written by lawyers for the companies in legalese, and they are written to protect the employer. Granted, a lot of the agreements are boilerplate that are common to all of these types of agreements. And even when the language may not look favorable to the employee it often may not make much difference. But sometimes the language is a big deal, and the devil is in the details.

In a mass layoff or reduction-in-force scenario, negotiating some of these terms may not be worthwhile because an employer isn’t going to want to do that with a thousand employees. But sometimes an agreement may impose new or unreasonable restrictions on an employee, such as making severance contingent on signing a broad non-compete agreement or something not part of the original employment agreement. This can be a major issue in a difficult job market, and it is often worth pushing back.

And sometimes an employee is included in a layoff as a convenient way to push out someone viewed as problematic - maybe they have taken leave under one of the provisions we spoke earlier about or have blown the whistle - and having an employment lawyer consider circumstances leading up to the termination can be useful. If such things have happened, there may be legal leverage to negotiate something better, or at least remove unfavorable terms.

The cost depends so much on the individual lawyer, the firm, the area of the country, etc. Generally a severance review and a consultation should take less than a couple of hours. If after the review, the attorney enters into negotiations on behalf of the employee, then it is likely to be longer and somewhat more costly. Less than a couple of hours for a review is going to be in the hundreds of dollars but not in the thousands of dollars, and the investment is worth it to understand your rights, obligations, and options.

CP: You mentioned non-compete agreements. If an employee is let go during the crisis do non-competes still automatically apply?

Michael: Generally a non-compete agreement will still apply unless the employer releases the employee either as part of a severance agreement or by virtue of some clause in their original agreement. For example, there may be a clause in an employment agreement that if someone is terminated without cause, as would be the case with a reduction-in-force, then the non-compete does not apply.

But the default in most layoffs will be for the non-compete to apply. Non-compete law varies a lot from state-to-state. Even within a state there is a balancing test between the legitimate interests of the company and the right of the employee to make a living. The result is that similar sets of facts sometimes lead to seemingly inconsistent results in the courts.

An example of the balancing test might be a non-compete for a rep whose territory is greater Philadelphia, and who only sells a particular asthma medicine. It likely would be unreasonable to prevent the employee from selling any other asthma medicine everywhere in the world, and it almost certainly would be unreasonable to prevent the rep from selling a cancer drug that indirectly competes with another product of the former employer. The restriction has to be reasonable in scope and duration. But the default is that whatever agreements you signed when you joined the company will remain in place unless they are contractually removed.