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Post by Chris-C on Feb 18, 2016 12:40:53 GMT -5
In reflecting on the unsuccessful MNKD partnership with SNY, it's worth remembering that in 2014, many were in agreement after FDA approval of Afrezza that it was wise for the company to find a partner because of its inexperience and lack of a marketing/sales infrastructure. In June 2014, the SP spiked over $11, and after the partnership was announced it surged to well over 10. It's clear to me that Mannkind expected that Sanofi was well suited to optimize the launch and distribution, providing a revenue stream adequate to discharge debt and commercialize other TS applications. MNKD certainly was in a position at that time to strengthen its cash reserves for contingencies, since even a 50M Share offering would have provided a $400-500M cash cushion. My point is that as a partner, Mannkind, after enduring Sanofi's poor results, could also have initiated the breakup had they been in a cash position to do so; and indeed it would have been the prudent thing to do. So one can view the SNY breakup as a negative event, or as a positive one.
Therefore, I'd have to say objectively that a break-up was absolutely necessary for Afrezza's future success. Their non-performance clearly shows that Brandicourt changed strategic direction and pulled the plug last Summer. Against this backdrop and the worry about operating cash, the science remains solid, the user results are extraordinary; and the barriers to success can be overcome. This says nothing of the patent portfolio and potential for other applications. As a subscriber to Nate's Notes, I agree with Mr. Pile's assessment that the risk reward picture still favors holding, and I am doing just that. Regards to all longs Chris C
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Post by centralcoastinvestor on Feb 18, 2016 15:33:14 GMT -5
In reflecting on the unsuccessful MNKD partnership with SNY, it's worth remembering that in 2014, many were in agreement after FDA approval of Afrezza that it was wise for the company to find a partner because of its inexperience and lack of a marketing/sales infrastructure. In June 2014, the SP spiked over $11, and after the partnership was announced it surged to well over 10. It's clear to me that Mannkind expected that Sanofi was well suited to optimize the launch and distribution, providing a revenue stream adequate to discharge debt and commercialize other TS applications. MNKD certainly was in a position at that time to strengthen its cash reserves for contingencies, since even a 50M Share offering would have provided a $400-500M cash cushion. My point is that as a partner, Mannkind, after enduring Sanofi's poor results, could also have initiated the breakup had they been in a cash position to do so; and indeed it would have been the prudent thing to do. So one can view the SNY breakup as a negative event, or as a positive one. Therefore, I'd have to say objectively that a break-up was absolutely necessary for Afrezza's future success. Their non-performance clearly shows that Brandicourt changed strategic direction and pulled the plug last Summer. Against this backdrop and the worry about operating cash, the science remains solid, the user results are extraordinary; and the barriers to success can be overcome. This says nothing of the patent portfolio and potential for other applications. As a subscriber to Nate's Notes, I agree with Mr. Pile's assessment that the risk reward picture still favors holding, and I am doing just that. Regards to all longs Chris C It seems to me that the Sanofi Board pulled the plug on Afrezza when they fired the old CEO and hired Brandicourt. I was too stupid to understand that, but I think I have company with that error. Initially, Mnkd management may have thought they would be OK. But I believe the Mnkd Board and Al knew after just a couple of months that they were in trouble. The reason I say that is that I noticed for most of last year, Hakan rarely spoke at anything but quarterly meetings. I thought this odd at the time, but now it makes sense. I believe Hakan was on his way out 8 months ago. It's unfortunate that the Desisto thing didn't work out, but I like Matt a lot. So no harm there IMHO. So here is a bold statement, I believe that Mnkd has been preparing for this split for about 8 months.
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Post by compound26 on Feb 18, 2016 15:43:29 GMT -5
In reflecting on the unsuccessful MNKD partnership with SNY, it's worth remembering that in 2014, many were in agreement after FDA approval of Afrezza that it was wise for the company to find a partner because of its inexperience and lack of a marketing/sales infrastructure. In June 2014, the SP spiked over $11, and after the partnership was announced it surged to well over 10. It's clear to me that Mannkind expected that Sanofi was well suited to optimize the launch and distribution, providing a revenue stream adequate to discharge debt and commercialize other TS applications. MNKD certainly was in a position at that time to strengthen its cash reserves for contingencies, since even a 50M Share offering would have provided a $400-500M cash cushion. My point is that as a partner, Mannkind, after enduring Sanofi's poor results, could also have initiated the breakup had they been in a cash position to do so; and indeed it would have been the prudent thing to do. So one can view the SNY breakup as a negative event, or as a positive one. Therefore, I'd have to say objectively that a break-up was absolutely necessary for Afrezza's future success. Their non-performance clearly shows that Brandicourt changed strategic direction and pulled the plug last Summer. Against this backdrop and the worry about operating cash, the science remains solid, the user results are extraordinary; and the barriers to success can be overcome. This says nothing of the patent portfolio and potential for other applications. As a subscriber to Nate's Notes, I agree with Mr. Pile's assessment that the risk reward picture still favors holding, and I am doing just that. Regards to all longs Chris C It seems to me that the Sanofi Board pulled the plug on Afrezza when they fired the old CEO and hired Brandicourt. I was too stupid to understand that, but I think I have company with that error. Initially, Mnkd management may have thought they would be OK. But I believe the Mnkd Board and Al knew after just a couple of months that they were in trouble. The reason I say that is that I noticed for most of last year, Hakan rarely spoke at anything but quarterly meetings. I thought this odd at the time, but now it makes sense. I believe Hakan was on his way out 8 months ago. It's unfortunate that the Desisto thing didn't work out, but I like Matt a lot. So no harm there IMHO. So here is a bold statement, I believe that Mnkd has been preparing for this split for about 8 months. That sounds reasonable. However, if that is true, Mannkind should definitely have done a secondary offering to raise at least $100-200 million when shares were trading at $5-6 around June last year.
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Post by lakers on Feb 18, 2016 16:17:10 GMT -5
Matt was so confident last May that Mnkd would have enough cash to pay off $100M note w/o diluting. I guess they expected some significant cash infusion events which fell through last minute. I don't want to say any more than that. Al didn't want to issue secondary offering when Pps > $10 b/c he thought Afrezza would be BB. Well no one but Tourbillon, AF, David Kliff foresaw Olivier wanted to drop Afrezza ASAP. Chris believed in Al and Afrezza. Olivier didn't.
That was the difference. The bright side is a reasonably commercial settlement. I expect > $200M, else a trebled $3B lawsuit. Sanofi knows how to pick their poison as any smart biz man. Either that or Al is forced to take Mnkd private for a song ($4/sh ?) as Nate feared. To Al, BK is not an option. It is a public humiliation, an insult to an injury inflicted by Sanofi. Nate understood Al's psychology well. I chalked it up as a lesson learned as Al never had to deal drug with a BP before. Either way Mnkd pps should improve in the next 6 mos.
In hindsight, investors should have bailed when Olivier was hired.
As of Sept 2015, Hakan still thought that Afrezza sale would increase after the typical 6-9 months to improve mkt access. He must have been misled by Sanofi whose only ulterior motive was dropping Afrezza ASAP as a hot potato to focus on Toujeo instead of co-marketing them together as they should. That's why he paid the price.
BoD started to realize Afrezza was in trouble in Oct, IMHO, then fired Hakan, then went to TASE to pull off a belatedly partial secondary offering.
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Post by mnholdem on Feb 18, 2016 17:53:48 GMT -5
Not that it matters much to MNKD shareholders at this point, but I've thought for some time now that Brandecourt/BoD is not pegging Sanofi's future on Toujeo. I believe that Toujeo is their stopgap until the drug they ARE banking their future diabetes franchise on gets approved. That drug is LixiLan - a combination basal/prandial. In retrospect, I find myself wondering if Brandecourt's intent was to delay Afrezza as long as possible to minimize the amount of market share Afrezza may have captured in the prandial insulin space. Sanofi knows Afrezza will be successful and that Toujeo is already facing (and losing) some stiff competition from Novo-Nordisk.
Sanofi's needs CEO could have immediately informed MannKind that he would be opting out of the Agreement. Why didn't he give MannKind the option of renegotiating an earlier termination? It seems obvious. Sanofi is a Goliath and they don't care about MannKind. How they end this may spell problems for their future. What other biotech / drug development company will want to do business with the French after it becomes apparent that they did indeed sandbag Afrezza?
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Post by Deleted on Feb 18, 2016 18:07:08 GMT -5
Not that it matters much to MNKD shareholders at this point, but I've thought for some time now that Brandecourt/BoD is not pegging Sanofi's future on Toujeo. I believe that Toujeo is their stopgap until the drug they ARE banking their future diabetes franchise on gets approved. That drug is LixiLan - a combination basal/prandial. In retrospect, I find myself wondering if Brandecourt's intent was to delay Afrezza as long as possible to minimize the amount of market share Afrezza may have captured in the prandial insulin space. Sanofi knows Afrezza will be successful and that Toujeo is already facing (and losing) some stiff competition from Novo-Nordisk. Sanofi's needs CEO could have immediately informed MannKind that he would be opting out of the Agreement. Why didn't he give MannKind the option of renegotiating an earlier termination? It seems obvious. Sanofi is a Goliath and they don't care about MannKind. How they end this may spell problems for their future. What other biotech / drug development company will want to do business with the French after it becomes apparent that they did indeed sandbag Afrezza? Lixilan is Basal + GLP-1 ? -- The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist
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Post by benyiju on Feb 18, 2016 20:13:32 GMT -5
Not that it matters much to MNKD shareholders at this point, but I've thought for some time now that Brandecourt/BoD is not pegging Sanofi's future on Toujeo. I believe that Toujeo is their stopgap until the drug they ARE banking their future diabetes franchise on gets approved. That drug is LixiLan - a combination basal/prandial. In retrospect, I find myself wondering if Brandecourt's intent was to delay Afrezza as long as possible to minimize the amount of market share Afrezza may have captured in the prandial insulin space. Sanofi knows Afrezza will be successful and that Toujeo is already facing (and losing) some stiff competition from Novo-Nordisk. Sanofi's needs CEO could have immediately informed MannKind that he would be opting out of the Agreement. Why didn't he give MannKind the option of renegotiating an earlier termination? It seems obvious. Sanofi is a Goliath and they don't care about MannKind. How they end this may spell problems for their future. What other biotech / drug development company will want to do business with the French after it becomes apparent that they did indeed sandbag Afrezza? This is certainly within the realm of possibility. More generally, I've long been curious why this class of drugs haven't played a bigger part in our conversations about Afrezza/MNKD's troubles, in terms of calculations of potential market share down the road.
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Post by Chris-C on Feb 18, 2016 22:11:42 GMT -5
Matt was so confident last May that Mnkd would have enough cash to pay off $100M note w/o diluting. I guess they expected some significant cash infusion events which fell through last minute. I don't want to say any more than that. Al didn't want to issue secondary offering when Pps > $10 b/c he thought Afrezza would be BB. Well no one but Tourbillon, AF, David Kliff foresaw Olivier wanted to drop Afrezza ASAP. Chris believed in Al and Afrezza. Olivier didn't. That was the difference. The bright side is a reasonably commercial settlement. I expect > $200M, else a trebled $3B lawsuit. Sanofi knows how to pick their poison as any smart biz man. Either that or Al is forced to take Mnkd private for a song ($4/sh ?) as Nate feared. To Al, BK is not an option. It is a public humiliation, an insult to an injury inflicted by Sanofi. Nate understood Al's psychology well. I chalked it up as a lesson learned as Al never had to deal drug with a BP before. Either way Mnkd pps should improve in the next 6 mos. In hindsight, investors should have bailed when Olivier was hired. As of Sept 2015, Hakan still thought that Afrezza sale would increase after the typical 6-9 months to improve mkt access. He must have been misled by Sanofi whose only ulterior motive was dropping Afrezza ASAP as a hot potato to focus on Toujeo instead of co-marketing them together as they should. That's why he paid the price. BoD started to realize Afrezza was in trouble in Oct, IMHO, then fired Hakan, then went to TASE to pull off a belatedly partial secondary offering. Lakers I hope you are correct about a settlement from Sanofi. It's becoming clearer that the account of events following Viebacher's ouster is very likely accurate; and if Mannkind was aware of this (or at least suspected it) they failed to take actions that would have put them in a better position at this point. Perhaps, as you suggest, this was Hakan's undoing. At the time late last year when Sanofi unveiled their strategic plan and mentioned Afrezza nowhere, that should have tipped us all off that a decision had been made. Only the shorts seemed to recognize that, as folks like me were in pathological denial. Sometimes, as the Three Mile Island debacle illustrated, the reactor is indeed melting down, and the instruments are telling the truth and should be taken at face value. One would think that even after having made the decision when they likely did, Sanofi would attempt to make a believable effort to demonstrate good faith execution of their part of the agreement, but the results since last Summer are a fact that cannot be hidden. If Mannkind did indeed suspect (or know) that a letter was coming, they didn't provide any clues. If anything, the CEO fiasco at the end of the year gave me grave concern that anyone in the boardroom or executive offices had their head screwed on straight. That series of events, after Hakan's pathetic plea for partners on a conference call, just added to the Street's lack of belief in Mannkind. I concede that event represents the point at which I had the least confidence in anything going right thereafter. I still find it inconceivable that Mannkind would announce DeSisto's hiring before vetting the non-complete provisions of his status. If, and when, the details of that story come out in the still to be written best seller about Mannkind, it will make for fascinating reading. And regarding Nate Pile's optimism about Mannkind as expressed in this thread, his latest missive reveals a pretty hefty buy order (200K shares) when the SP was .67. This guy has been through a few rodeos. Cheers, Chris C
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Post by Deleted on Feb 18, 2016 22:28:26 GMT -5
Matt was so confident last May that Mnkd would have enough cash to pay off $100M note w/o diluting. I guess they expected some significant cash infusion events which fell through last minute. I don't want to say any more than that. Al didn't want to issue secondary offering when Pps > $10 b/c he thought Afrezza would be BB. Well no one but Tourbillon, AF, David Kliff foresaw Olivier wanted to drop Afrezza ASAP. Chris believed in Al and Afrezza. Olivier didn't. That was the difference. The bright side is a reasonably commercial settlement. I expect > $200M, else a trebled $3B lawsuit. Sanofi knows how to pick their poison as any smart biz man. Either that or Al is forced to take Mnkd private for a song ($4/sh ?) as Nate feared. To Al, BK is not an option. It is a public humiliation, an insult to an injury inflicted by Sanofi. Nate understood Al's psychology well. I chalked it up as a lesson learned as Al never had to deal drug with a BP before. Either way Mnkd pps should improve in the next 6 mos. In hindsight, investors should have bailed when Olivier was hired. As of Sept 2015, Hakan still thought that Afrezza sale would increase after the typical 6-9 months to improve mkt access. He must have been misled by Sanofi whose only ulterior motive was dropping Afrezza ASAP as a hot potato to focus on Toujeo instead of co-marketing them together as they should. That's why he paid the price. BoD started to realize Afrezza was in trouble in Oct, IMHO, then fired Hakan, then went to TASE to pull off a belatedly partial secondary offering. Lakers I hope you are correct about a settlement from Sanofi. It's becoming clearer that the account of events following Viebacher's ouster is very likely accurate; and if Mannkind was aware of this (or at least suspected it) they failed to take actions that would have put them in a better position at this point. Perhaps, as you suggest, this was Hakan's undoing. At the time late last year when Sanofi unveiled their strategic plan and mentioned Afrezza nowhere, that should have tipped us all off that a decision had been made. Only the shorts seemed to recognize that, as folks like me were in pathological denial. Sometimes, as the Three Mile Island debacle illustrated, the reactor is indeed melting down, and the instruments are telling the truth and should be taken at face value. One would think that even after having made the decision when they likely did, Sanofi would attempt to make a believable effort to demonstrate good faith execution of their part of the agreement, but the results since last Summer are a fact that cannot be hidden. If Mannkind did indeed suspect (or know) that a letter was coming, they didn't provide any clues. If anything, the CEO fiasco at the end of the year gave me grave concern that anyone in the boardroom or executive offices had their head screwed on straight. That series of events, after Hakan's pathetic plea for partners on a conference call, just added to the Street's lack of belief in Mannkind. I concede that event represents the point at which I had the least confidence in anything going right thereafter. I still find it inconceivable that Mannkind would announce DeSisto's hiring before vetting the non-complete provisions of his status. If, and when, the details of that story come out in the still to be written best seller about Mannkind, it will make for fascinating reading. And regarding Nate Pile's optimism about Mannkind as expressed in this thread, his latest missive reveals a pretty hefty buy order (200K shares) when the SP was .67. This guy has been through a few rodeos. Cheers, Chris C Does he shares these positions verbally or visual proof. I've had brief interaction with him through social media and seems like a very nice guy. I wish he"d stop arguing on stock twits with the mutants.
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Post by esstan2001 on Feb 19, 2016 6:29:55 GMT -5
Matt was so confident last May that Mnkd would have enough cash to pay off $100M note w/o diluting. I guess they expected some significant cash infusion events which fell through last minute. I don't want to say any more than that. Al didn't want to issue secondary offering when Pps > $10 b/c he thought Afrezza would be BB. Well no one but Tourbillon, AF, David Kliff foresaw Olivier wanted to drop Afrezza ASAP. Chris believed in Al and Afrezza. Olivier didn't. That was the difference. The bright side is a reasonably commercial settlement. I expect > $200M, else a trebled $3B lawsuit. Sanofi knows how to pick their poison as any smart biz man. Either that or Al is forced to take Mnkd private for a song ($4/sh ?) as Nate feared. To Al, BK is not an option. It is a public humiliation, an insult to an injury inflicted by Sanofi. Nate understood Al's psychology well. I chalked it up as a lesson learned as Al never had to deal drug with a BP before. Either way Mnkd pps should improve in the next 6 mos. In hindsight, investors should have bailed when Olivier was hired. As of Sept 2015, Hakan still thought that Afrezza sale would increase after the typical 6-9 months to improve mkt access. He must have been misled by Sanofi whose only ulterior motive was dropping Afrezza ASAP as a hot potato to focus on Toujeo instead of co-marketing them together as they should. That's why he paid the price. BoD started to realize Afrezza was in trouble in Oct, IMHO, then fired Hakan, then went to TASE to pull off a belatedly partial secondary offering. Lakers I hope you are correct about a settlement from Sanofi. It's becoming clearer that the account of events following Viebacher's ouster is very likely accurate; and if Mannkind was aware of this (or at least suspected it) they failed to take actions that would have put them in a better position at this point. Perhaps, as you suggest, this was Hakan's undoing. At the time late last year when Sanofi unveiled their strategic plan and mentioned Afrezza nowhere, that should have tipped us all off that a decision had been made. Only the shorts seemed to recognize that, as folks like me were in pathological denial. Sometimes, as the Three Mile Island debacle illustrated, the reactor is indeed melting down, and the instruments are telling the truth and should be taken at face value. One would think that even after having made the decision when they likely did, Sanofi would attempt to make a believable effort to demonstrate good faith execution of their part of the agreement, but the results since last Summer are a fact that cannot be hidden. If Mannkind did indeed suspect (or know) that a letter was coming, they didn't provide any clues. If anything, the CEO fiasco at the end of the year gave me grave concern that anyone in the boardroom or executive offices had their head screwed on straight. That series of events, after Hakan's pathetic plea for partners on a conference call, just added to the Street's lack of belief in Mannkind. I concede that event represents the point at which I had the least confidence in anything going right thereafter. I still find it inconceivable that Mannkind would announce DeSisto's hiring before vetting the non-complete provisions of his status. If, and when, the details of that story come out in the still to be written best seller about Mannkind, it will make for fascinating reading. And regarding Nate Pile's optimism about Mannkind as expressed in this thread, his latest missive reveals a pretty hefty buy order (200K shares) when the SP was .67. This guy has been through a few rodeos. Cheers, Chris C Chris, a lot resonates here- great post. And misery loves company :-)
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Post by yash on Feb 19, 2016 7:32:17 GMT -5
The shorts were aware, the GS was aware.
Was Mannkind management aware? I hope so. Then why they failed to take action?
Because the Mannkind management hands were tied as the first right for refusal was with SNY until Jan'16.
I think SNY should pay a big settlement amount to MNKD for sandbagging Afrezza intentionally else they well deserve for a lawsuit.
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Post by mnholdem on Feb 19, 2016 7:49:13 GMT -5
Not that it matters much to MNKD shareholders at this point, but I've thought for some time now that Brandecourt/BoD is not pegging Sanofi's future on Toujeo. I believe that Toujeo is their stopgap until the drug they ARE banking their future diabetes franchise on gets approved. That drug is LixiLan - a combination basal/prandial. In retrospect, I find myself wondering if Brandecourt's intent was to delay Afrezza as long as possible to minimize the amount of market share Afrezza may have captured in the prandial insulin space. Sanofi knows Afrezza will be successful and that Toujeo is already facing (and losing) some stiff competition from Novo-Nordisk. Lixilan is Basal + GLP-1 ? -- The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist @iam2sekc4u2002 , you are correct.
A second late-stage study of LixiLan, which marries its GLP-1 drug Lyxumia and the basal insulin Lantus, came up positive, Sanofi ($SNY) announced Monday. The study tested LixiLan in patients who were struggling to control their blood sugar despite basal insulin treatment alone and found that those taking LixiLan saw better results than those taking Lantus, with or without metformin.
"The result highlights that this could provide a treatment option for the roughly 50% of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment," study investigator Richard Bergenstal of the International Diabetes Center in Minnesota said in a statement.
LixiLan's particular selling point is that it's the only fixed-dose combo pairing basal insulin and a GLP-1. "This is a very synergistic combination," Sanofi EVP Peter Guenter said during the company's first-quarter earnings call, adding that the drug had been "a little bit overlooked" by financial analysts at that point. "I must say we are pretty excited about this product."
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Sanofi CEO Olivier Brandecourt, in a Feb. 9, 2016 video interview, has this to say:
"Looking to the future of our franchise, we expect a U.S. regulatory decision on Lixilan which we submitted to the FDA in December using a priority review voucher. In Europe, the submission of Lixilan is planned for this quarter."
Source: www.multivu.com/players/English/7753751-sanofi-2015-annual-results/docs/transcript-2111519257.pdf
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That priority review voucher cost Sanofi $millions and its use confirms that LixiLan has become a very high priority for this global giant. I think it's entirely feasible that Brandecourt's strategy with MannKind was to delay market acceptance of Afrezza for as long as possible.
Obviously, that's only my opinion. There is no proof.
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Post by bradleysbest on Feb 19, 2016 10:38:17 GMT -5
Who really knows but that is a very real possibility MN.
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Post by agedhippie on Feb 19, 2016 12:58:34 GMT -5
That was the difference. The bright side is a reasonably commercial settlement. I expect > $200M, else a trebled $3B lawsuit. Read the contract. Lawsuits are explicitly ruled out in Article 14.
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Post by mnholdem on Feb 19, 2016 14:11:00 GMT -5
"14.3 Court Actions. Nothing contained in this Agreement shall deny either Party the right to seek, upon good cause, injunctive or other equitable relief from a court of competent jurisdiction in the context of an emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing dispute resolution discussions or arbitration proceedings."
There's always a catch... and there is in this Agreement that enables MannKind to seek damages, provided it's done within the statute of limitations.
The point is that Sanofi can NOT smugly say, "So, messieurs, go ahead and try to sue us!" If MannKind determines that Sanofi has, indeed, inflicted irreparable harm, they can move outside the arbitration provision.
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