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Post by lakers on Jan 5, 2016 21:39:30 GMT -5
if Sanofi is the Breaching Party and the breach is with respect to Sanofi’s failure to comply with its obligation to use Commercially Reasonable Efforts with respect to (x) the United States, MannKind may terminate this Agreement in its entirety, and (y) any Major Market (other than the United States) or […***…] Country, MannKind may terminate this Agreement only with respect to such Major Market or […***…] Country (as applicable) and not in its entirety. If the Breaching Party disputes in good faith that it has materially breached one of its obligations under this Agreement, termination shall not take effect pending resolution of such dispute pursuant to Article 14. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of one or more of its obligations under this Agreement (an “Adverse Ruling”), then if the Breaching Party fails to complete the actions specified by the Adverse Ruling to cure such breach within ninety (90) days (or forty five (45) days for any payment breach) after such Adverse Ruling, then the Complaining Party may terminate this Agreement upon written notice to the Breaching Party. www.sec.gov/Archives/edgar/data/899460/000119312514406347/d783199dex101.htm1. Sny didn't start several post mktg studies on time, and filed to delay lung study. 2. Sny knew that superiority study was key to Tier placement but chose not to start it late 2014 and 2015 3. Intransigent on price resulting in poor mkt access 4. A few print Ads didn't cut it. No internet, Social media Ads let alone TV Ads. No NEJM articles. 5. Reasonable effort was defined as at least same effort as Sny's leading diabetes. AFZ mktg effort was far below that of Lantus, Toujeo, Apidra. 6. Mkt cap should increase significantly when Mnkd file a law suit for ~$2B. 7. Sny didn't even try to expand internationally. Many foreign countries have national health care, single payor systems. 8. No effort made to improve label. The potential law suit should entice a premium outright sale of AFZ franchise. Together with $1.5B dev tax loss credit, Mnkd is a very attractive acquisition target. |
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Post by mnholdem on Jan 5, 2016 21:53:15 GMT -5
That's irrelevant at this point. In fact, Sanofi terminating the agreement is better by far since it stays out of the courts. Sanofi could have continued its sandbagging and forced MannKind to keep paying expenses. They made their decision and got out at the earliest date contractually permissible of January 1, 2016.
MannKind didn't get hurt that bad. We retail shareholders who are long in MNKD are the ones that took it on the chin. I fully expect CEO DeSisto to rectify the situation and to kick some ass (to paraphrase a past comment of his) to turn this around.
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Post by lakers on Jan 5, 2016 21:59:37 GMT -5
Sanofi delayed drug to avoid $708 mln in payments, lawsuit claims
By Brendan Pierson
Nov 9 (Reuters) - A new lawsuit accuses Sanofi SA of stalling development of its multiple sclerosis drug Lemtrada to avoid paying out at least $708 million to rights holders under its 2011 agreement to acquire Genzyme Corp.
The lawsuit, filed on Monday in Manhattan federal court by American Stock Transfer & Trust Co LLC, a trustee for the rights holders, seeks at least $236.1 million in damages.
Genzyme was in the process of developing Lemtrada when Sanofi bought it. Under the merger agreement, Sanofi issued Genzyme shareholders tradable certificates entitling them to payments if Lemtrada won approval from the U.S. Food and Drug Administration by March 31, 2014, and further payments if it met certain sales benchmarks after that.
Sanofi promised it would make "diligent efforts" to meet those goals, according to the complaint. Instead, the trustee alleges, it deliberately took a "slow path" to bring Lemtrada to market.
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The lawsuit claims Sanofi deliberately ignored the FDA's concerns about the designs of its clinical trials, leading the agency to deny the company's first application for approval.
The trustee further claims that even after Lemtrada was finally approved in November 2014, Sanofi skimped on marketing it, while actively promoting a different multiple sclerosis drug, Aubagio. As a result, the lawsuit says, Lemtrada has failed to meet any of the sales benchmarks.
The drug is expected to lose patent protection in September 2017, according to the lawsuit, further limiting its prospects.
Sanofi said in a statement that it was aware of the lawsuit but did not comment on pending litigation.
The case is American Stock Transfer & Trust Company LLC v. Sanofi, U.S. District Court, Southern District of New York, No. 1:15-cv-08725. (Reporting by Brendan Pierson in New York; Editing by Matthew Lewis)
Mgmt would be negligent not to file a law suit against Sanofi. It has a great case on lack of Commercially Reasonable Effort.
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Post by bradleysbest on Jan 5, 2016 22:04:00 GMT -5
But at what cost ? Does funding a lawsuit shorten the clock on operations if a TS deal is not found soon ?
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Post by lakers on Jan 5, 2016 22:10:08 GMT -5
But at what cost ? Does funding a lawsuit shorten the clock on operations if a TS deal is not found soon ? For a highly winnable case, law firms normally charges nothing to plaintiffs in exchange for a percentage. If Sny settles or ruled to pay $1B, the law firm may take 20-30% cut and the losing party would pay for the winner's litigation cost. This case would cost Mnkd nothing for as long as the court takes. A law suit should unlock SH value. The Breaching Party is clearly Sny. Once the suit filed, Sny may initially offer to pay what left in the milestone payments 925-200 = $725M at min. I'd use it as a low bar. Mnkd may ask much more than that using Lantus lifetime sale as the benchmark. Actually, Sny did a big favor for Mnkd by terminating the partnership. Mnkd would have to sell a lot of AFZ in the next 10 years to make the same 35% profit as the $725M plus settlement/damage. IMHO, Mnkd will likely get at least the entire $925M from Sny without much effort. |
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Post by mnkdmorelong on Jan 5, 2016 22:30:11 GMT -5
But at what cost ? Does funding a lawsuit shorten the clock on operations if a TS deal is not found soon ? For a highly winnable case, law firms normally charges nothing to plaintiffs in exchange for a percentage. If Sny settles or ruled to pay $1B, the law firm may take 20-30% cut. This case would cost Mnkd nothing for as long as the court takes. A law suit should unlock SH value. The Breaching Party is clearly Sny. Once the suit filed, Sny may initially offer to pay what left in the milestone payments 925-200 = $725M at min. I'd use it as a low bar. Mnkd may ask much more than that using Lantus lifetime sale as the benchmark. Whoa, slow down. Lawyer's fees for these types of lawsuits are paid for by the parties. Discovery and Depositions will run millions. Then there is the trial (if at all). It will take at least 3 years depending on the court to get to trial. MNKD must prove that SNY did not perform as per the contract. How are they going to do this? Pfizer's Exubera also failed. This will be SNY's defense. How is a jury going to sort through all this and decide? SNY has much more money than MNKD. They will not offer to pay for anything. In fact, they may extend Discovery and be aggressive with motion practice to make it more costly for MNKD. |
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Post by 4allthemarbles on Jan 5, 2016 22:30:19 GMT -5
Is this plausible? Meaning, would it be worth to pursue (even if there is no cost to MNKD)?
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Post by chuck on Jan 5, 2016 22:35:39 GMT -5
Literally days ago lakers was saying the partnership was strong. Now he's saying things were so bad that mnkd should sue. You couldn't make this stuff up. Lurching from one wild theory to the next.
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Post by lakers on Jan 5, 2016 22:36:14 GMT -5
For a highly winnable case, law firms normally charges nothing to plaintiffs in exchange for a percentage. If Sny settles or ruled to pay $1B, the law firm may take 20-30% cut. This case would cost Mnkd nothing for as long as the court takes. A law suit should unlock SH value. The Breaching Party is clearly Sny. Once the suit filed, Sny may initially offer to pay what left in the milestone payments 925-200 = $725M at min. I'd use it as a low bar. Mnkd may ask much more than that using Lantus lifetime sale as the benchmark. Whoa, slow down. Lawyer's fees for these types of lawsuits are paid for by the parties. Discovery and Depositions will run millions. Then there is the trial (if at all). It will take at least 3 years depending on the court to get to trial. MNKD must prove that SNY did not perform as per the contract. How are they going to do this? Pfizer's Exubera also failed. This will be SNY's defense. How is a jury going to sort through all this and decide? SNY has much more money than MNKD. They will not offer to pay for anything. In fact, they may extend Discovery and be aggressive with motion practice to make it more costly for MNKD. Pfizer spent more than 10X to market Exubera. The JAC meeting minutes have been kept and will serve as evidence. It's an easy case. See my previous posts and lawyer payment. It would cost Mnkd zero to follow through the law suit. |
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Post by lorcan458 on Jan 5, 2016 22:38:29 GMT -5
Lakers' list is all very supportable from a legal point of view and having two simultaneous lawsuits for the same type of behavior will reinforce each other. I'm sure the list gets quite a bit longer when it includes all the behind the scenes information that Mannkind has that we retail shareholders don't know about. There are plenty of law firms who will take the case with no up-front costs for Mannkind and in I think Mannkind has a moral obligation to help discourage big pharma from behaving in the way Sanofi has.
Once Afrezza is priced on par with injectables, the year of real world results will make it a lot more likely for tier 2 placement. Mannkind can even offer a discount card or make it slightly less expensive to start since they have so much inventory and a contract to keep buying insulin. Script count is far more important right now than profit margin. If scripts can be pushed up in the exponential rate that they should be, the share price will recover to a level that will make raising money from minor dilution much more palatable to us longs.
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Post by ricguy on Jan 5, 2016 22:40:20 GMT -5
didnt Hakan or someone on a previous CC say they were pleased with sny efforts or something in that regard(not pleased with sales but had no issue with sny). I remember that vaguely. prob said to appease us investors but even if mnkd decided to file a lawsuit which right now they are just trying to survive, statements like that would be picked apart.
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Post by lakers on Jan 5, 2016 22:45:54 GMT -5
Literally days ago lakers was saying the partnership was strong. Now he's saying things were so bad that mnkd should sue. You couldn't make this stuff up. Lurching from one wild theory to the next. 12/31/15 I said: I'd imagine both TEVA and GSK want Mnkd's TS. I refrain from saying the not obvious ... Hakan said Mnkd at its core is a drug dev co. As such, Afrezza may potentially be spun off. The remaining co will focus on drug dev alone, not mfgr. With upcoming partnerships, BoD may potentially consider spinning off to increase SH value. Mnkd announced they are exploring strategic options for AFZ. Mgmt was also blindsided as well. They really thought Sny would expend more effort this year. They received Sanofi's notice just yesterday 1/4/16. Read more: mnkd.proboards.com/thread/4643/mannkind-approach-gsk-ts-migraine#ixzz3wOVO3Yjr |
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Post by greg on Jan 5, 2016 22:47:33 GMT -5
First, I agree with a lot of points made by Lakers.
"MNKD must prove that SNY did not perform as per the contract. How are they going to do this? Pfizer's Exubera also failed. This will be SNY's defense. How is a jury going to sort through all this and decide?"
Exubera failed for multiple well defined reasons. 1) Diabetics didn't like Exubera because it was a gigantic device that was difficult to carry around and use. That's not all, there was absolutely nothing special about the insulin dispensed; 2) Physicians didn't like Exubera because it was difficult to use and there was nothing special about the insulin dispensed; and 3) Insurance companies didn't like Exubera because there was nothing special about the insulin dispensed and it sold at a huge premium to SQ insulin.
WHY did SNY choose to terminate the agreement? We don't really know. The company claims in a brief statement that it made a substantial effort but all the points made by Lakers strongly undermine those claims.
I'm guessing MannKind, as the junior partner with minimal resources, and led by Edstrom, whom nobody would confuse with a Trump, was pushed around by SNY and had very little say in how the so-called partnership conducted business.
I think a lawsuit would be money well spent.
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Post by greg on Jan 5, 2016 23:02:48 GMT -5
Literally days ago lakers was saying the partnership was strong. Now he's saying things were so bad that mnkd should sue. You couldn't make this stuff up. Lurching from one wild theory to the next. I don't think there's an inconsistency in those positions. I, too, thought the partnership was strong, but this was based on my assessment that SNY was proceeding in a methodical manner. I assumed things that needed to be done would be done in due course, based on a time table it, as the expert, deemed best. As it turns out, SNY wasn't proceeding in a methodical manner, what we got was all we were going to get. There was nothing to come in due course. |
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Post by esstan2001 on Jan 5, 2016 23:13:57 GMT -5
Sanofi delayed drug to avoid $708 mln in payments, lawsuit claims By Brendan Pierson Nov 9 (Reuters) - A new lawsuit accuses Sanofi SA of stalling development of its multiple sclerosis drug Lemtrada to avoid paying out at least $708 million to rights holders under its 2011 agreement to acquire Genzyme Corp. The lawsuit, filed on Monday in Manhattan federal court by American Stock Transfer & Trust Co LLC, a trustee for the rights holders, seeks at least $236.1 million in damages. Genzyme was in the process of developing Lemtrada when Sanofi bought it. Under the merger agreement, Sanofi issued Genzyme shareholders tradable certificates entitling them to payments if Lemtrada won approval from the U.S. Food and Drug Administration by March 31, 2014, and further payments if it met certain sales benchmarks after that. Sanofi promised it would make "diligent efforts" to meet those goals, according to the complaint. Instead, the trustee alleges, it deliberately took a "slow path" to bring Lemtrada to market. ADVERTISEMENT The lawsuit claims Sanofi deliberately ignored the FDA's concerns about the designs of its clinical trials, leading the agency to deny the company's first application for approval. The trustee further claims that even after Lemtrada was finally approved in November 2014, Sanofi skimped on marketing it, while actively promoting a different multiple sclerosis drug, Aubagio. As a result, the lawsuit says, Lemtrada has failed to meet any of the sales benchmarks. The drug is expected to lose patent protection in September 2017, according to the lawsuit, further limiting its prospects. Sanofi said in a statement that it was aware of the lawsuit but did not comment on pending litigation. The case is American Stock Transfer & Trust Company LLC v. Sanofi, U.S. District Court, Southern District of New York, No. 1:15-cv-08725. (Reporting by Brendan Pierson in New York; Editing by Matthew Lewis) Mgmt would be negligent not to file a law suit against Sanofi. It has a great case on lack of Commercially Reasonable Effort. Look at who filed this lawsuit- AST&TC LLC; are they representing the company or the shareholders? Be great if they took this on for shareholders and institutions- |
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