|
Post by bioexec25 on Nov 30, 2015 8:22:24 GMT -5
I have gone through the Sanofi/MNKD agreement with fine tooth comb and then the comb broke after learning/reading 99.9% of this signed agreement is in favor of Sanofi. There is less than 1/10 of a % that leaves MNKD any wiggle room. It is almost like taking Afrezza, giving Sanofi the rights to put Afrezza in an unmarked box, unopened box, placing it on the shelf. If this is true and Al is finally realizing that the deal is bad, all the more reason for me (and all investors in my opinion) to want to see one partner notify the other of intention to terminate the partnership. I'd prefer MNKD to terminate, but if SNY does, I'll take that too. The drug works, and I'm convinced at this point that the primary reason that we haven't seen more sales is because SNY doesn't want there to be any, for whatever reason or another. If we aren't seeing substantial improvements in insurance coverages either, it begs the question "Just what HAS Sanofi been doing this whole time?" The bare minimum it appears. I concur with other posters in the belief that Al will fund the company as necessary in the near term and I also have to believe that a competitor to SNY would be interested in taking a drug that SNY once had and making it successful not only to steal what could have been their revenue, but also to throw it in their face. I'll use the word that everyone hates, but I HOPE that Al is fed up at this point and is prepared to take action, which he now can do as CEO. Fortune favors the bold and at this point, we have almost nowhere to go but up. We might as well take the shot. Novo steps in pairing Tresiba + Afrezza?
|
|
|
Post by mindovermatter on Nov 30, 2015 9:31:43 GMT -5
Guys, I've been hearing things on twitter / cafepharma over the last few months about a "pilot program" for Afrezza. See here: cafepharma.com/boards/threads/does-sanofi-rank-sales-people-selling-afrezza.584319/Based on the the Nrx and Trx numbers we've been seeing (which have been strangely constant), is it possible that this drug really hasn't even been launched on what would be considered a full-scale launch for a company. I mean, the consistency in scripts is just plain weird. It's as if Sanofi hasn't even hit the gas pedal yet. Could the last 12 months simply have been a pilot program as referred to in the thread above? Where Sanofi effectively took Afrezza for a test-drive? Could be one of the reasons for the confidential treatment order. Just a thought! Could be or maybe Sanofi is purposefully gas lighting Mannkind by not pushing Afrezza to as many doctors as it could and purposefully not negotiating with insurance companies to get Al to come down in his asking sell price. But as I have said before, we don't know what is going on because of so called confidentiality provisions.
|
|
|
Post by bill on Nov 30, 2015 9:32:35 GMT -5
If this is true and Al is finally realizing that the deal is bad, all the more reason for me (and all investors in my opinion) to want to see one partner notify the other of intention to terminate the partnership. I'd prefer MNKD to terminate, but if SNY does, I'll take that too. The drug works, and I'm convinced at this point that the primary reason that we haven't seen more sales is because SNY doesn't want there to be any, for whatever reason or another. If we aren't seeing substantial improvements in insurance coverages either, it begs the question "Just what HAS Sanofi been doing this whole time?" The bare minimum it appears. I concur with other posters in the belief that Al will fund the company as necessary in the near term and I also have to believe that a competitor to SNY would be interested in taking a drug that SNY once had and making it successful not only to steal what could have been their revenue, but also to throw it in their face. I'll use the word that everyone hates, but I HOPE that Al is fed up at this point and is prepared to take action, which he now can do as CEO. Fortune favors the bold and at this point, we have almost nowhere to go but up. We might as well take the shot. Novo steps in pairing Tresiba + Afrezza? Based on the partnership agreement, what clause do you think MNKD would invoke that would allow them to sell Afrezza to Novo without SNY retaining the rights to Afrezza? I don't see such an option. In fact I see just the opposite.
|
|
|
Post by silentknight on Nov 30, 2015 10:47:46 GMT -5
12.2 Termination by the Parties.
(a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, 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...
I'd say based on that provision of the contract, if MNKD feels that SNY hasn't lived up to what they expected with respect to Afrezza's marketing, they have an out. Granted nobody knows what was agreed to in reference to "Commercially Reasonable Efforts" and the big "x" is labeled as confidential, but from the basic look of it, MNKD could make the argument to terminate I believe. It would likely have to navigate the 90-day period for SNY to potentially address any perceived shortfalls. I'm no lawyer but on the verbiage alone, I think MNKD could make a good argument for termination.
|
|
|
Post by rrtzmd on Nov 30, 2015 10:58:54 GMT -5
12.2 Termination by the Parties. (a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, 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... I'd say based on that provision of the contract, if MNKD feels that SNY hasn't lived up to what they expected with respect to Afrezza's marketing, they have an out. Granted nobody knows what was agreed to in reference to "Commercially Reasonable Efforts" and the big "x" is labeled as confidential, but from the basic look of it, MNKD could make the argument to terminate I believe. It would likely have to navigate the 90-day period for SNY to potentially address any perceived shortfalls. I'm no lawyer but on the verbiage alone, I think MNKD could make a good argument for termination. The problem is that MNKD agreed to work via the "joint committee" to resolve all disputes. Per the agreement, the final decision regarding any dispute is left to the Sanofi co-chairman of that committee, and you realize, of course, how he will vote. I doubt that there's much legal recourse given that agreement.
|
|
|
Post by sweedee79 on Nov 30, 2015 11:39:41 GMT -5
The problem I have with this theory is that both MNKD and SNY have said they are disappointed with the sales thus far. If it was just a pilot program why would they be disappointed with the sales? MNKD is in financial trouble, so I think its time to get this ball rolling and soon. Also the sudden resignation of Hakan says something as well. There is something going on and its not good. Sorry if I sound pessimistic but this is the gut feelings that I have and I trust my instincts. I just pray that MNKD has a plan for further financing, but then we go further in debt. Whatever SNY's plan is... they better move on it we don't have all the time in the world.
|
|
|
Post by mindovermatter on Nov 30, 2015 11:43:06 GMT -5
The problem I have with this theory is that both MNKD and SNY have said they are disappointed with the sales thus far. If it was just a pilot program why would they be disappointed with the sales? MNKD is in financial trouble, so I think its time to get this ball rolling and soon. Also the sudden resignation of Hakan says something as well. There is something going on and its not good. Sorry if I sound pessimistic but this is the gut feelings that I have and I trust my instincts. I just pray that MNKD has a plan for further financing, but then we go further in debt. Whatever SNY's plan is... they better move on it we don't have all the time in the world. Because even with "pilot" programs, there are projections made just like anything else that is sold. And it looks like Sanofi's internal projections were way off assuming the pilot program is what Sanofi is doing.
|
|
|
Post by sweedee79 on Nov 30, 2015 11:45:17 GMT -5
I hope that is the case....
|
|
|
Post by trenddiver on Nov 30, 2015 11:48:58 GMT -5
12.2 Termination by the Parties. (a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, 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... I'd say based on that provision of the contract, if MNKD feels that SNY hasn't lived up to what they expected with respect to Afrezza's marketing, they have an out. Granted nobody knows what was agreed to in reference to "Commercially Reasonable Efforts" and the big "x" is labeled as confidential, but from the basic look of it, MNKD could make the argument to terminate I believe. It would likely have to navigate the 90-day period for SNY to potentially address any perceived shortfalls. I'm no lawyer but on the verbiage alone, I think MNKD could make a good argument for termination. The problem is that MNKD agreed to work via the "joint committee" to resolve all disputes. Per the agreement, the final decision regarding any dispute is left to the Sanofi co-chairman of that committee, and you realize, of course, how he will vote. I doubt that there's much legal recourse given that agreement. In addition, if Sanofi challenges Mannkind's assertions, there is a legal process that will have to play itself out which could be very expensive and could take years. If that happens, Afrezza will at best just limp along or worse just die on the vine. Trend
|
|
|
Post by dictatorsaurus on Nov 30, 2015 11:50:38 GMT -5
The problem I have with this theory is that both MNKD and SNY have said they are disappointed with the sales thus far. If it was just a pilot program why would they be disappointed with the sales? MNKD is in financial trouble, so I think its time to get this ball rolling and soon. Also the sudden resignation of Hakan says something as well. There is something going on and its not good. Sorry if I sound pessimistic but this is the gut feelings that I have and I trust my instincts. I just pray that MNKD has a plan for further financing, but then we go further in debt. Whatever SNY's plan is... they better move on it we don't have all the time in the world. Exactly! I've been thinking the same since the very beginning. All this talk about a "pilot" program yet scripts are closely monitored and discussed. If this was a pilot neither SNY nor MNKD would seem concerned. Both have expressed their dissatisfaction with sales. What puzzles me is how they even expect the product to sell without a proper large scale advertising campaign. I've spoken to at least a dozen diabetics and not a single one of them knew about Afrezza. To be brutally honest, none of them even seemed interested despite the great results and ease of use. Diabetics are a strange breed. Most don't seem to care much about properly controlling the disease. They are so set in their ways and cynical about any sort of new treatment. Sam Finta said it best when he said most diabetics are walking around not aware how sick they are and the damage they are causing to their organs. I've witnessed first hand the damage this disease inflicts, and it's not pretty at all!
|
|
|
Post by sweedee79 on Nov 30, 2015 11:51:39 GMT -5
In the event that MNKD terminates the partnership do they then have to pay back the initial payment they received from SNY and could they afford it??? It will take money, lawyers and time to get out of this...
|
|
|
Post by dreamboatcruise on Nov 30, 2015 12:07:12 GMT -5
The problem I have with this theory is that both MNKD and SNY have said they are disappointed with the sales thus far. If it was just a pilot program why would they be disappointed with the sales? MNKD is in financial trouble, so I think its time to get this ball rolling and soon. Also the sudden resignation of Hakan says something as well. There is something going on and its not good. Sorry if I sound pessimistic but this is the gut feelings that I have and I trust my instincts. I just pray that MNKD has a plan for further financing, but then we go further in debt. Whatever SNY's plan is... they better move on it we don't have all the time in the world. Exactly! I've been thinking the same since the very beginning. All this talk about a "pilot" program yet scripts are closely monitored and discussed. If this was a pilot neither SNY nor MNKD would seem concerned. Both have expressed their dissatisfaction with sales. What puzzles me is how they even expect the product to sell without a proper large scale advertising campaign. I've spoken to at least a dozen diabetics and not a single one of them knew about Afrezza. To be brutally honest, none of them even seemed interested despite the great results and ease of use. Diabetics are a strange breed. Most don't seem to care much about properly controlling the disease. They are so set in their ways and cynical about any sort of new treatment. Sam Finta said it best when he said most diabetics are walking around not aware how sick they are and the damage they are causing to their organs. I've witnessed first hand the damage this disease inflicts, and it's not pretty at all! What you say about patients is likely especially applicable to T2. From the beginning of the disease they are told that if they get their act together they can stop/reverse the disease with diet and exercise. Each progression in treatment involves some degree of self admission to failure. I think many simply wish to think as little as they can about the situation. Unfortunately, the current prescribing regimes of orals almost assure that the disease will worsen. It will be important to have doctors on board because I suspect many T2 would need to be pushed into initiating insulin... even if it is more patient/lifestyle friendly version.
|
|
|
Post by rrtzmd on Nov 30, 2015 12:22:17 GMT -5
Exactly! I've been thinking the same since the very beginning. All this talk about a "pilot" program yet scripts are closely monitored and discussed. If this was a pilot neither SNY nor MNKD would seem concerned. Both have expressed their dissatisfaction with sales. What puzzles me is how they even expect the product to sell without a proper large scale advertising campaign. I've spoken to at least a dozen diabetics and not a single one of them knew about Afrezza. To be brutally honest, none of them even seemed interested despite the great results and ease of use. Diabetics are a strange breed. Most don't seem to care much about properly controlling the disease. They are so set in their ways and cynical about any sort of new treatment. Sam Finta said it best when he said most diabetics are walking around not aware how sick they are and the damage they are causing to their organs. I've witnessed first hand the damage this disease inflicts, and it's not pretty at all! What you say about patients is likely especially applicable to T2. From the beginning of the disease they are told that if they get their act together they can stop/reverse the disease with diet and exercise. Each progression in treatment involves some degree of self admission to failure. I think many simply wish to think as little as they can about the situation. Unfortunately, the current prescribing regimes of orals almost assure that the disease will worsen. It will be important to have doctors on board because I suspect many T2 would need to be pushed into initiating insulin... even if it is more patient/lifestyle friendly version. Current protocols from both the ADA and AACE put prandial insulin as the very last resort in attempting to control hyperglycemia in treating type 2 diabetes. For obese patients, even bariatric surgery now ranks higher: AACE type 2 protocol
|
|
|
Post by mnholdem on Nov 30, 2015 12:31:23 GMT -5
In the event that MNKD terminates the partnership do they then have to pay back the initial payment they received from SNY and could they afford it??? It will take money, lawyers and time to get out of this... The correction to this misconception has been posted before, but perhaps you missed it, sweedee79. The bottom line is that the License & Collaboration Agreement clearly states that MannKind Corporation does NOT have to pay back any upfront or milestone payments whatsoever.
The only money owed to Sanofi will be the balance of the Sanofi Loan Facility, which has been used to pay MNKD's portion of expenses thus far. Even this does not have to be paid to Sanofi until 2023, as Hakan pointed out to a GS advisor at the last cc.
----
IMO, all this talk about either party ending the Agreement is bordering on FUD, with the emphasis on the "U" for Uncertainty.
|
|
|
Post by bill on Nov 30, 2015 12:53:34 GMT -5
What you say about patients is likely especially applicable to T2. From the beginning of the disease they are told that if they get their act together they can stop/reverse the disease with diet and exercise. Each progression in treatment involves some degree of self admission to failure. I think many simply wish to think as little as they can about the situation. Unfortunately, the current prescribing regimes of orals almost assure that the disease will worsen. It will be important to have doctors on board because I suspect many T2 would need to be pushed into initiating insulin... even if it is more patient/lifestyle friendly version. Current protocols from both the ADA and AACE put prandial insulin as the very last resort in attempting to control hyperglycemia in treating type 2 diabetes. For obese patients, even bariatric surgery now ranks higher: AACE type 2 protocolVery sad. It seems those guidelines are designed to minimize the risk of hypoglycemia so they leave prandial insulin as the medication of last resort. The makes an unfortunate association between increased hypoglycemia risk and prandial insulin. Unfortunately for T2 diabetics, Afrezza might actually be most effective as a first choice medication. First, it replaces the first phase insulin response which is what T2's initially lose. Second, is not very likely to induce hypoglycemia because of its rapid action, and third it may allow the pancreas to recover and function normally again. Sigh...
|
|