Trell

Trell

Audioholic Samurai
Oh, I agree. 277 different vaccines is a vast waste of time effort and expense.
We don't know a priori which of these vaccines will work or what various side effects they have. This is also an excellent opportunity to learn how to quickly make new vaccines, test, manufacture and distribute them. For what is certain is more pandemics are coming, and I for sure don't like to beholden to a company or two.

An added issue is patents, and I'm sure that is a big motivation as well, and of course, researches like to research and money is flowing into this area.
 
Irvrobinson

Irvrobinson

Audioholic Spartan
Now the Biden administration wants to grant an IP waiver for vaccine patents:


Talk about a dumb idea. The US and the EU have had multiple manufacturing snafus, and that's with the developing companies directly involved in the process. I don't think I'd take a vaccine developed just by lifting patent protection. Are the patents really enough? I'm a skeptic.

Fortunately, lifting the patent protection internationally requires a consensus vote. I can't believe every country will vote for this proposal.
 
GO-NAD!

GO-NAD!

Audioholic Spartan
We don't know a priori which of these vaccines will work or what various side effects they have. This is also an excellent opportunity to learn how to quickly make new vaccines, test, manufacture and distribute them. For what is certain is more pandemics are coming, and I for sure don't like to beholden to a company or two.

An added issue is patents, and I'm sure that is a big motivation as well, and of course, researches like to research and money is flowing into this area.
I don't disagree with any of your statements. Still, 277 seems like a tremendous duplication of effort.
 
panteragstk

panteragstk

Audioholic Spartan
Now the Biden administration wants to grant an IP waiver for vaccine patents:


Talk about a dumb idea. The US and the EU have had multiple manufacturing snafus, and that's with the developing companies directly involved in the process. I don't think I'd take a vaccine developed just by lifting patent protection. Are the patents really enough? I'm a skeptic.

Fortunately, lifting the patent protection internationally requires a consensus vote. I can't believe every country will vote for this proposal.
Well, I get that it's in the interest in having herd immunity across the globe, but it also comes back to the 277 other variants being worked on. If they have the IP from the current, successful, vaccines, why take the time and expense to make their own?
 
Irvrobinson

Irvrobinson

Audioholic Spartan
Well, I get that it's in the interest in having herd immunity across the globe, but it also comes back to the 277 other variants being worked on. If they have the IP from the current, successful, vaccines, why take the time and expense to make their own?
My guesses? Oral vaccines, nasal vaccines, vaccines that last longer, vaccines that are more effective *and* last longer...

When the world is at war, everyone thinks they need to build weapons.
 
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Swerd

Swerd

Audioholic Warlord
My guesses? Oral vaccines, nasal vaccines, vaccines that last longer, vaccines that are more effective *and* last longer...

When the world is at war, everyone thinks they need to build weapons.
Those are good guesses. To your list, I would add vaccines that are easier to store. Such as freeze-dried (lyophilized) vaccines that don't require -70° F storage, and can be reconstituted with sterile water shortly before use.

Remember that the handful of vaccines we now have were the vaccines that we could produce and test as quickly as possible. They were never meant to be the vaccine that finally ends the SARS-CoV-2 threat. Those 2nd generation vaccines are still in development.
 
M

Mr._Clark

Audioholic Chief
Now the Biden administration wants to grant an IP waiver for vaccine patents:


Talk about a dumb idea. The US and the EU have had multiple manufacturing snafus, and that's with the developing companies directly involved in the process. I don't think I'd take a vaccine developed just by lifting patent protection. Are the patents really enough? I'm a skeptic.

Fortunately, lifting the patent protection internationally requires a consensus vote. I can't believe every country will vote for this proposal.
This has generated a lot of discussion in the IP world.

Dennis Crouch makes makes some good points in a recent blog post.

First, there are (apparently) no issued patents in many countries (e.g. India) that would block production as of right now ("If we take India as an example, right now there are no patents that have been granted in India tied directly to the COVID response. So, allowing India to waive its promise to enforce patents does not generate any short-term gains.)(editorial comment: this ignores the risk that a patent could issue any day)

Second, trade secrets are big issue.

>>>Trade secrets are different, most of the “intellectual property” wrapped up in COVID vaccine manufacture is currently being held as trade secrets. Obviously the companies manufacturing the product have the information. Many countries also have information that they received in the process of (1) funding the research and (2) determining whether to allow the vaccines to be distributed. International espionage is also a major element here that will put the information in the hands of various governmental agencies.<<<

The original proposed waiver would have waived trade secret protection (I'm not sure what the latest proposal says about trade secrets). As Crouch points out, even if companies refuse to share trade secrets it's possible that someone will disclose it Wikileaks style. Absent trade secret protection in foreign countries, the companies will have little recourse in the event of an unauthorized disclosure.

If trade secrets are waived, it provides an additional incentive for companies to guard information even more closely going forward (e.g. keep the information locked down rather than rely on confidentiality agreements).


 
GO-NAD!

GO-NAD!

Audioholic Spartan
One month ago, Nova Scotia had 36 active cases. Today - 1309. :oops: Went for my fourth asymptomatic test yesterday - still negative.
 
Irvrobinson

Irvrobinson

Audioholic Spartan
This has generated a lot of discussion in the IP world.

Dennis Crouch makes makes some good points in a recent blog post.

First, there are (apparently) no issued patents in many countries (e.g. India) that would block production as of right now ("If we take India as an example, right now there are no patents that have been granted in India tied directly to the COVID response. So, allowing India to waive its promise to enforce patents does not generate any short-term gains.)(editorial comment: this ignores the risk that a patent could issue any day)

Second, trade secrets are big issue.

>>>Trade secrets are different, most of the “intellectual property” wrapped up in COVID vaccine manufacture is currently being held as trade secrets. Obviously the companies manufacturing the product have the information. Many countries also have information that they received in the process of (1) funding the research and (2) determining whether to allow the vaccines to be distributed. International espionage is also a major element here that will put the information in the hands of various governmental agencies.<<<

The original proposed waiver would have waived trade secret protection (I'm not sure what the latest proposal says about trade secrets). As Crouch points out, even if companies refuse to share trade secrets it's possible that someone will disclose it Wikileaks style. Absent trade secret protection in foreign countries, the companies will have little recourse in the event of an unauthorized disclosure.

If trade secrets are waived, it provides an additional incentive for companies to guard information even more closely going forward (e.g. keep the information locked down rather than rely on confidentiality agreements).


Good points about trade secrets. Just out of curiosity, how would trade secret protection waivers get companies to reveal these documents? Patents are published; it's obviously just a matter of law that prevents people from infringing on them, and even then mostly the courts. Trade secret documents are themselves secret, even their existence, and they're private property. What legal basis would there be in the US to force a company to share trade secret documents? Wouldn't just the search for the documents be a 4th Amendment violation?
 
Swerd

Swerd

Audioholic Warlord
It's those trade secrets that can make or break the whole vaccine. For example, the entire process of making those mRNA vaccines is probably covered by a number of different patents. That might include how to chemically modify the mRNA molecule itself to inhibit it's degradation.

But other details of preserving the modified mRNA from rapid degradation may very well be trade secrets. That might include how to package the mRNA in those lipid nanoparticles, what the exact composition of lipids goes into making the nanoparticles, and what other non-lipid additives that aid in stability might be included. All of those details probably took a large amount of boring trial & error research. And none of them were publishable as new science, as was the mRNA portion of the vaccines.

All this is guessing, as I have no direct information about these matters. If I did know any of these details, I would have signed comprehensive confidentiality agreements and could not mention it here without personal risk.
 
M

Mr._Clark

Audioholic Chief
Good points about trade secrets. Just out of curiosity, how would trade secret protection waivers get companies to reveal these documents? Patents are published; it's obviously just a matter of law that prevents people from infringing on them, and even then mostly the courts. Trade secret documents are themselves secret, even their existence, and they're private property. What legal basis would there be in the US to force a company to share trade secret documents? Wouldn't just the search for the documents be a 4th Amendment violation?
Keep in mind that TRIPS involves the laws of each country that is a member of treaty. Essentially, the current proposals state the the member countries agree not to enforce TRIPS provisions against other countries, should those countries decide not to allow/enforce covid related patents.

The WIPO website has a pretty decent description of trade secret protection:

>>>Most countries provide for remedies in criminal, administrative, commercial and/or civil law, in particular, tort law, contractual law and specific legislation on unfair competition.
In general, a trade secret owner can collect damages from the person who violated the trade secret for the economic injury suffered. The trade secret laws of some countries might also permit the use of injunctions, which requires the cessation of the use of any products that have been created through the use of trade secret information contrary to honest commercial practices. In some countries, for particular cases of trade secret violation, criminal penalties are available.<<<


It's not uncommon for companies to disclose trade secrets to other companies under nondisclosure agreements. Trade secrets are not necessarily "secret" in an absolute sense, it's a legal term that applies if a court determines that the information in question meets the legal requirements to qualify as a trade secret. Basically, a court needs to determine 1) is the information really a trade secret? and 2) did the defendant misappropriate the trade secret? Unlike patents, a court will decide whether or not the information is a trade secret based on the facts of each case. The party asserting trade secret misappropriation won't know for sure if they actually have trade secret rights until after the courts decides. It's the act of misappropriating the trade secret that creates legal liability.

I don't think a waiver would, by itself, cause the companies to disclose their trade secrets.

I think Crouch is concerned that someone who has access to to the trade secrets would post them in a public forum. This could of course happen regardless of whether or not there is a trade secret waiver. However, absent a waiver, anyone posting or using the trade secrets would face potential legal liability.

In the context of the proposed TRIPS waiver, I'm not sure what legal basis might be used to force a U.S. company to disclose trade secrets to foreign governments or companies. Keep in mind that it depends on who is trying to do the forcing. Between private parties it's conceivable that there could be a contractual obligation to disclose and the party that wants the information could ask a court to enforce the contract. The Defense Production ACT (DPA) is a REALLY BIG stick that might give the federal government the power to force a company to disclose trade secrets. I'm not sure if the DPA has been used to force disclosure of trade secrets in the past, but using the DPA to force disclosure to foreign entities in connection with a TRIPS waiver strikes me as highly questionable.

I doubt that there would be significant 4th amendment issues. Keep in mind that the Bill of Rights limits the power of the government. It is not uncommon during civil litigation between private parties for a court to order production of company documents during discovery under a protective order.

The more likely issue, at least to my mind, is a 5th Amendment takings clause issue ( “Nor shall private property be taken for public use, without just compensation.”) It seems to me that it would be difficult to show that waiving treaty rights by the government constitutes a taking of private property.
 
M

Mr._Clark

Audioholic Chief
I ran across an article at wired.com about vaccine statistics and relative risk reduction (RRR) vs absolute risk reduction (ARR). Here's a snip:

>>>You could also, of course, calculate the absolute risk reduction. That’s simply the difference in risk for someone in the treatment group versus someone in the control group. Here’s an example: Say you have 100 people who don’t get a vaccine, and you find that 10 of them catch the disease. So the baseline risk of getting it is 10%. And suppose that 100 other people get the vaccine, and only one of these gets sick. Their risk is 1%. The absolute risk reduction is then just 9% (10% minus 1%), because the risk was already pretty low. But the relative risk reduction is 90%—that reduction of 9% divided by the baseline risk of 10%.

As a commentary in Lancet Microbe pointed out last month, even with trials on tens of thousands of people, the absolute risk reductions in Covid-19 vaccine trials are teensy-tiny—a reduction in the risk of getting severe Covid of just 1.2% for Moderna and a scant 0.84% for Pfizer. “One of the main reasons why absolute risk reduction is not shown is because of the numbers. If you say, ‘It’s 95% effective’—wow!” says Piero Olliaro, an infectious disease researcher at the University of Oxford’s Centre for Tropical Medicine and Global Health and one of the authors of the Lancet Microbe article. “But if your absolute risk reduction is like 0.8% or whatever it was, so what?”<<<
I'm curious what others think about this?

It seems to me that ARR based on a trial can be misleading because it is dealing with a relatively short period of time and not very many people who are not vaccinated will get COVID due to teh short time period of the trial. In my estimation, over a long enough period of time one's odds of getting infected are very high if one does not get vaccinated (a statistician once told me that there is a theorem stating that if the probability of an event is greater than zero, the odds of the event occurring are 100% given an infinite amount of time).

Using a modified version of the Wired hypothetical, I suspect that over a long enough period of time roughly 70 of the 100 unvaccinated people would catch the disease (some would be infected but not actually develop symptoms, so the % will never hit 100%), whereas 7 in the vaccinated group would get the disease (I'm assuming of course that the ratio between the 2 groups is consistent over time). This would lead to an ARR of 63% (70% minus 7%).

In other words, it seems to me that using the ARR from a trial is potentially misleading because a relatively small percentage of people will be infected over a short period of time, but in the real world we can't just stop the clock after 3 or 4 months and declare that the trial is over.

Somewhat similarly, a COVID skeptic said to me early in the pandemic that "Your odds of dying from it are one in a million!" because at that time only about one person in a million in this country had died from it. My response was that my odds of having already died from it were zero (unless I was actually starring in a Bruce Willis ghost movie of some sort), but that doesn't mean my odds are zero or one in a million in the future.

Am I missing something here?

 
M

Mr._Clark

Audioholic Chief
Here's another article (link below) about the TRIPS waiver (law360 is pretty well-respected within the legal profession).

One additional thought on this. In theory, a country could continue to reject patent applications for COVID related inventions indefinitely. This would allow domestic companies in that country to use the inventions without infringing any issued patents. This would of course be corrupt and it would violate TRIPS, but it might be difficult to prove that any given patent office was intentionally delaying patent applications. Patentability varies somewhat from country to country, and very few patent applications are clearly allowable over the prior art. There is almost always some prior art that must be overcome in order to get a patent. The patent office could say "We are just applying our laws to this application in the same manner as every other patent application."

This would become less plausible if patents for the same inventions are allowed in numerous other countries.

A side note: I have had numerous patent applications for the same invention on file in various countries at the same time. A rejection of an application in one country is typically posted on that country's patent office website, so examiners in other countries can see if the same application was rejected in other countries. This leads to all sorts of lazy behavior by examiners around the world. Basically, examiners stall examination and wait for rejections in other countries, then copy the rejections rather than doing their own search and examination. For example, a couple years ago I had a case pending in India and at the European Patent Office (EP) at the same time, and the examiner in India would wait for Office Actions in the EP case and copy them (i.e. citing the same prior art, but rewording the rejection so it was purportedly based on Indian law). At the risk of getting too far off track, this is especially annoying because the EPO has (in my opinion) gone off the rails lately in order to clear pending patent applications (i.e. by rejecting them) to make way for the Unified Patent and Unified Patent Court (https://www.epo.org/law-practice/unitary.html). A very high percentage of patents that are filed in various countries are filed in the EPO, and the pattern that has developed is that examiners around the world tend to wait for rejections by the EPO then copy the rejections. Of course, one is required to pay patent application filing and examination fees for "examination" that often involve little more than copy cat rejections from other countries (U.S. examiners will do the same thing given the chance, which is why it is typically best (in my opinion) to fie a U.S. utility application at the same time a PCT application is filed)(the U.S. examiner will not be able to stall long enough to copy rejections in foreign countries, so it tends to be easier to get an application allowed before all of the copycat rejections start popping up in the corresponding foreign cases)(once the copying gets started, the thinking seems to be "this application was rejected by by 7 other patent offices on the same basis, so it must be a solid rejection and I'll just copy them" even though the first rejection in the chain might have been garbage that was copied).

Apologies for the rather long off topic rant. I'm sure other patent lawyers would disagree with my assesment, so take it with grain a salt.

 
M

Mr._Clark

Audioholic Chief
Here's an article by a guy from BIO (a trade group) discussing the TRIPS waiver. It's actually a pretty decent article (BIO obviously has a stake in this, but a lot of what they put out is actually quite informative).

I believe the following is correct:

>>>In a nutshell, WTO members would be released from their obligation under TRIPS to grant new patents, copyrights, and protections for industrial designs, trade secrets, regulatory data, and business confidential information and materials. Member countries would also be absolved from enforcing already-existing protections, in each case for an undetermined number of years “in relation to [the] prevention, containment or treatment of COVID-19,” until “widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.”<<<

I'm not sure the following is 100% correct, but it's worth thinking about it as a potential issue:

>>>One wonders whether Congressional proponents of the TRIPS Waiver have given any thought as to how it could be implemented in U.S. law. There is no mechanism in U.S. law for simply waiving vested IP rights. Amendments to the federal patent, copyright, food and drug, and other federal statutes would need to be attempted; trade secret protections under 50 state laws overridden; and the waiver’s interference with the IP and confidentiality provisions of myriad existing private contracts would need to be sorted out.<<<

It's not clear to me that the proposed TRIPS waivers would actually require the U.S. to amend its laws. As I understand it, the waiver just says countries have the option to do so without incurring penalties under the TRIPS agreement (in other words, my understanding is that he is correct when he says that the WTO members would be "released from their obligation" but I do not believe this mandates elimination of IP rights for COVID vaccines in each country). That's not to say there wouldn't be political pressure to nuke COVID IP rights in this country.

Some of the comments are also interesting. Ron Katznelson makes some good points. He's fairly well-known in IP circles. I do not always agree with him, but he's no dummy ("Anon" posts frequently posts comments on ipwatchdog, but he seems to mostly just chase his tail without ever really making a point)

 
M

Mr._Clark

Audioholic Chief
Here's another blog post that is informative. The author is a patent lawyer and he has a PhD in molecular biology and a law degree.

>>>The plain language of the press release, and the focus of the waiver that has evolved, is to include all intellectual property. This would include trade secrets, and that raises a serious issue. As explicated by Derek Lowe in his article "Myths of Vaccine Manufacturing," the rate-limiting step for COVID vaccine production (at least for the mRNA-based vaccines) involves proprietary machines and methods for making the vaccine that are, more than likely, not covered by patents and never will be. The technological circumstances surrounding vaccine production involve trade secrets regarding formulation of vaccines that are what can be the bottleneck in the process. But trade secrets are the type of property the rights to which cannot be suspended; disclosure destroys the secret and thus the property. It is unlikely that companies will voluntarily give up their valuable trade secrets, and while there might perhaps be some stomach for forcing them to in some jurisdictions, it is unlikely that the U.S. will be one of them.

But this "moveable feast" of policy rationales illustrates the political fact that the aim and goal of this and other proposals by India, South Africa, and other countries is to escape the TRIPS requirement for recognizing and enforcing IP protections, imposed as part of the requirements for WTO membership. When these facts are considered, the call by these governments (and others) should be understood for what it is: an attempt to use the pandemic to achieve a goal of status quo ante (prior to the establishment of the GATT/TRIPS/WTO global trade and patent regime), which was imposed upon these and other countries a generation ago. The COVID pandemic provides the humanitarian reason for a solution that isn't a solution but that resonates with uninformed (albeit generally well-meaning) politicians, humanitarians, and religious and non-governmental organizations. <<<

It's hard to know from the outside looking in what trade secrets might be involved. One major problem is that a forced disclosure in one country would destroy rights everywhere. On the other hand, it's not clear that a court in any given country would have jurisdiction to successfully force a disclosure against a U.S. company. Also, it's not clear that a forced disclosure of only some trade secrets would be sufficient. Assuming numerous companies in the U.S. have their own trade secrets, it's hard to see how a court in (for example) South Africa could issue a legally enforceable ruling that would force all U.S. companies involved in vaccine manufacture to disclose everything they know about the process (in layman's terms, I suspect that U.S. companies would just give them bird and cease operating in the country that issued the order).

This could lead to political pressure in the U.S. to change U.S. laws here to force across the board trade secret disclosures by U.S. companies. I have a hard time seeing congress moving forward with this if push comes to shove.

 
Irvrobinson

Irvrobinson

Audioholic Spartan
Here's another blog post that is informative. The author is a patent lawyer and he has a PhD in molecular biology and a law degree.

>>>The plain language of the press release, and the focus of the waiver that has evolved, is to include all intellectual property. This would include trade secrets, and that raises a serious issue. As explicated by Derek Lowe in his article "Myths of Vaccine Manufacturing," the rate-limiting step for COVID vaccine production (at least for the mRNA-based vaccines) involves proprietary machines and methods for making the vaccine that are, more than likely, not covered by patents and never will be. The technological circumstances surrounding vaccine production involve trade secrets regarding formulation of vaccines that are what can be the bottleneck in the process. But trade secrets are the type of property the rights to which cannot be suspended; disclosure destroys the secret and thus the property. It is unlikely that companies will voluntarily give up their valuable trade secrets, and while there might perhaps be some stomach for forcing them to in some jurisdictions, it is unlikely that the U.S. will be one of them.

But this "moveable feast" of policy rationales illustrates the political fact that the aim and goal of this and other proposals by India, South Africa, and other countries is to escape the TRIPS requirement for recognizing and enforcing IP protections, imposed as part of the requirements for WTO membership. When these facts are considered, the call by these governments (and others) should be understood for what it is: an attempt to use the pandemic to achieve a goal of status quo ante (prior to the establishment of the GATT/TRIPS/WTO global trade and patent regime), which was imposed upon these and other countries a generation ago. The COVID pandemic provides the humanitarian reason for a solution that isn't a solution but that resonates with uninformed (albeit generally well-meaning) politicians, humanitarians, and religious and non-governmental organizations. <<<

It's hard to know from the outside looking in what trade secrets might be involved. One major problem is that a forced disclosure in one country would destroy rights everywhere. On the other hand, it's not clear that a court in any given country would have jurisdiction to successfully force a disclosure against a U.S. company. Also, it's not clear that a forced disclosure of only some trade secrets would be sufficient. Assuming numerous companies in the U.S. have their own trade secrets, it's hard to see how a court in (for example) South Africa could issue a legally enforceable ruling that would force all U.S. companies involved in vaccine manufacture to disclose everything they know about the process (in layman's terms, I suspect that U.S. companies would just give them bird and cease operating in the country that issued the order).

This could lead to political pressure in the U.S. to change U.S. laws here to force across the board trade secret disclosures by U.S. companies. I have a hard time seeing congress moving forward with this if push comes to shove.

I love it when experts and I are on the same page. It almost makes me feel smart.
 
Irvrobinson

Irvrobinson

Audioholic Spartan
Unless the US and other vaccine development countries can figure out a way to legally force vaccine development companies to give up so-called trade secrets, and it would have to include criminal penalties (or how would you ever know you got it all), the more I think about it the more I think this waiver is a non-event for fighting the pandemic in the near term. By the time anyone figures how to replicate the current vaccine production without deep assistance, the next generation vaccines will be available, and they'll have to start all over again. In fact, it would seem the wisest move for (what I'm going to call) a forger would be to wait until the next generation IP is available and start there. If I were the drugs companies doing the basic development I might consider not filing patents at all. That way everything is a trade secret. I wonder how easy it is to detect patent infringement in this field?
 
TLS Guy

TLS Guy

Audioholic Slumlord
Much progress is being made, but huge problems remain.

Everyone knew the virus would find the unvaccinated.

In the USA now, 22% of patients hospitalized with Covid-19 are children. In Minnesota as of this last week the figure was 26%. Tragically we lost a first grader, with no underlying risk factors a few days ago. So we do need to get children immunized as quickly as it is safe to do so.

Sinovax is a problem as it is certainly less than 40% effective, best estimates around 37%. So that has potential to do more harm than good.

Variants are a concern. The UK B.117 variant seems to outspread the rest, which is probably a good thing, as vaccines have equal effectiveness against this variant.

Vaccine resistance is of concern with Brazil P1 and the South African B.1351. The B.1351 seems most resistant. The P1 is concerning because if its high reinfection rate.
Although vaccine effectiveness is significantly reduced against these strains, the vaccines are still largely preventing serious illness and especially death.

Due to the chaos in India it is hard to asses vaccine resistance of their variants. The UK B.117 however is increasingly dominant there, indicating the Indian variants may well be less transmissible.

The dauting issue though is the sheer numbers of people still to be vaccinated, and how to produce the number of vaccines required.

The mDNA vaccines have a slight advantage as the Nano shields are hard to produce. As far as I can tell most Nano shields are produced in the US and UK. mDNA vaccines require difficult to maintain renal cell lines.

Bangladesh is an object lesson. On the face of it, they have good manufacturing capability. They tried to produce their own vaccine, Bangavax. No I'm not making that up. The serum institute tried to help them produce the AstraZeneca vaccine, but could not get a consistent product. Now the Russians are trying to help them produce Sputnik V.

So it is not a matter about releasing patents. It is far more complex than that. Of course the looney left, think distributing vaccine technology is like issuing a recipe to bake a cake. The build whole anticapitalistic conspiracy theories around this. Conspiracy theories are certainly not the preserve of the far right.

That is the best summary of the state of things I can put together at this time.
 

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