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Post by Omega on Jun 13, 2018 16:49:45 GMT -5
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 13 June 2018
ORDER GRANTING CONFIDENTIAL TREATMENT UNDER THE SECURITIES EXCHANGE ACT OF 1934 MannKind Corporation File No. 0-50865 -- CF# 36331 _____________________ MannKind Corporation submitted an application under Rule 24b-2 requesting
confidential treatment for information it excluded from the Exhibits to a Form 10-Q filed
on May 9, 2018.
Based on representations by MannKind Corporation that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be released to the public for the time period(s) specified: Exhibit 10.8 through December 31, 2023 For the Commission, by the Division of Corporation Finance, pursuant to delegated authority: Brent J. Fields Secretary www.sec.gov/Archives/edgar/data/899460/999999999718006373/filename1.pdfwww.sec.gov/Archives/edgar/data/899460/999999999718006373/9999999997-18-006373-index.htm
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Post by dg1111 on Jun 13, 2018 17:06:47 GMT -5
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Post by mannmade on Jun 13, 2018 17:09:22 GMT -5
Partner? IDK but one can dream...
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Post by Omega on Jun 13, 2018 17:12:54 GMT -5
Exhibit 10.8
***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and Rule 24b-2 THIRD AMENDMENT TO SUPPLY AGREEMENT This third amendment (“Third Amendment”) to the Supply Agreement by and between MannKind Corporation (“MannKind”) and Amphastar Pharmaceuticals, Inc. (“Amphastar”), originally dated July 31, 2014 and as previously amended on October 31, 2014 and November 9, 2016 (collectively, the “Agreement”), is hereby made as of the 11th day of April, 2018, by and between MannKind on the one hand, and on the other hand, Amphastar. RECITALS: WHEREAS, MannKind and Amphastar entered into the Agreement pursuant to which Amphastar is to manufacture and supply the Product to MannKind, and MannKind is to purchase certain minimum quantities of the Product; WHEREAS, any distribution or sales by MannKind of the Product or the MannKind Product made using the Product shall be limited to the Territory; and WHEREAS MannKind and Amphastar have determined it to be mutually beneficial to amend the Agreement as set forth herein. NOW, THEREFORE, for good and valuable consideration, MannKind and Amphastar, hereby agree to amend the Agreement as follows: 1. Definitions. Unless otherwise defined herein, each of the capitalized terms used in this Third Amendment shall have the definition and meaning ascribed to it in the Agreement. 2. Amendments to the Agreement. 2.1 Section 1.4 of the Agreement is amended and replaced in its entirety with the following: “‘Excluded Countries’ means […***…]” 3. Final Agreement. From and after the execution of this Third Amendment, all references in the Agreement (or in the Third Amendment) to “this Agreement,” “hereof,” “herein,” “hereto,” and similar words or phrases shall mean and refer to the Agreement as amended by this Third Amendment. The Agreement as amended by this Third Amendment constitutes the entire agreement by and between the Parties as to the subject matter hereof. Except as expressly modified by this Third Amendment, all other terms and conditions of the Agreement shall remain in full force and effect. investors.mannkindcorp.com/static-files/af1d14e2-e1ea-45f4-8d72-b1578f4a3b17#page65
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Post by dg1111 on Jun 13, 2018 17:20:53 GMT -5
Partner? IDK but one can dream... Knowing that there are some signed term sheets for international expansion and Amphastar has right of refusal for China, I tend to get my hopes up. But owning this stock has taught me to keep realistic expectations.
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Post by mannmade on Jun 13, 2018 17:24:44 GMT -5
If it were truly bad news wouldn’t they have to disclose as material to shareholders? Asking...
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Post by peppy on Jun 13, 2018 17:29:15 GMT -5
If it were truly bad news wouldn’t they have to disclose as material to shareholders? Asking... do you mean wouldn't they have to tell shareholders what countries are excluded?
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Post by mannmade on Jun 13, 2018 17:49:35 GMT -5
Yes or if it were anticipated to negatively effect stock price.
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Post by babaoriley on Jun 13, 2018 18:00:20 GMT -5
Not much but my psyche is negatively affected by all this crap.
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Post by hellodolly on Jun 13, 2018 18:44:45 GMT -5
Means nothing either way but, we will have our slew of keyboard insiders offering their best guess. I can't wait for tomorrow at 0600 to read.
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Post by jred on Jun 13, 2018 20:13:03 GMT -5
Numerous times in the past they have applied for an exemption just to keep the details of the purchase agreement with Amphastar confidential (specific insulin quantities and prices). Since this is only relating to an exhibit I would expect the same in this case. My long MNKD optimism is looking for a reduction in the outstanding commitment, but that is just hope so far.
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Post by peppy on Jun 13, 2018 20:57:36 GMT -5
From quarter 1 CC: MIKE C "Post Q1, we've had other significant milestones. We raised $26.3 million in the month of April. We executed this morning our license agreement with India with Cipla, which I'll talk about. We completed our REMS program earlier than expected. And the Afrezza inhaler device was approved in Brazil last week. The reason that is important as it makes sure that we continue on progress for our Brazilian filing" seekingalpha.com/article/4171963-mannkinds-mnkd-ceo-michael-castagna-q1-2018-results-earnings-call-transcript?part=single"Let me take a second and talk about global expansion. As we know, it's not an urgent need for this year, but it's something that had we not started last year we'd be sitting here waiting to continue to build out additional revenue streams and opportunities to help people living with diabetes around the world. Last year, we announced Brazil. That remains on track. We are excited to see that hopefully get approved in late Q4 or early Q1 this year. The second one we just announced is India, this morning, with Cipla. So with this announcement, one in four people living with diabetes will have the option for Afrezza as we continue to expand. And we expect this to potentially get approved as soon as six month, but more realistically 12 to 24 months. We anticipate a small Phase 3 trial will be required, but here is a chance under new Indian SCFDA guidelines that we could get approval sooner. We have already started working with our partner on articulating the medical strategy and the regulatory strategy, so we've already got a head start prior to today's announcement. We're also working on additional filings in other markets, and I hope to be able to share some of that information with you soon. Additionally, we have started negotiating term sheets for some other key markets which we will try to get done in second quarter but it could go into third quarter. The reason we selected Cipla is because we believe they are one of the top leaders in healthcare within India. They understand the market. They have infrastructure in diabetes, and they have 70% market share in respiratory products. So when you think about a partner being able to understand the inhalation aspects of the drug and having diabetes experience is really incredible. You may or may not know, they also had inhaled insulin in their pipeline that they were struggling with, and this really allows us to bring a partner in who is already striving to achieve what we've already accomplished. We believe they'll be a great partner, and it's already been an extremely collaborative relationship." ================================================================================================== I thought I remembered Mike saying something about Amphstar. I did not find it.
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