|
Post by mssciguy on Nov 23, 2015 21:34:33 GMT -5
It's Sanofi who cannot develop a competing API for five years, as one of the conditions for being given the right to manufacture Technosphere particles within the terms of the agreement. I'm mobile at the mo', so I don't have the Agreement at my fingertips, but I think it was in Article 5, perhaps? www.sec.gov/Archives/edgar/data/899460/000119312514406347/d783199dex101.htmWe need LAWYERS 5.1 Commercialization of Product. (a) Sanofi Responsibilities. Sanofi shall have the exclusive right to Commercialize Product in the Field in the Territory during the Term, subject to the terms and conditions of this Agreement. Without limiting the foregoing, during the Term, Sanofi will have the exclusive right and responsibility, at Sanofi’s sole expense (but subject to EXHIBIT B), for the following with respect to Product in the Field in the Territory: (i) establish the Commercialization and marketing strategy and tactics (the “Commercial Strategy”); (ii) establishing pricing and reimbursement, including payment of applicable rebates and chargebacks; (iii) managed care and government contracting (including contracting for the Product to be available under the Government Health Care Programs); (iv) receiving, accepting and filling orders; (v) distribution to customers; 26. (vi) controlling invoicing, order processing and collecting accounts receivable for sales; (vii) recording sales in its books of account for sales; and (viii) tracking and reporting transfers of value in connection with Product under applicable state and federal “aggregate spend”/“sunshine” reporting laws (except to the extent legally the responsibility of the Licensors).
|
|
|
Post by mnholdem on Nov 24, 2015 9:54:06 GMT -5
I was off a few sections... but I was spot on about Sanofi having to wait five years. It seems to me that at the rate they're moving, we may have to consider this non-complete clause a little more carefully.
---
1.27 “Competing Product” shall mean any product (other than Product) containing or comprising any formulation of Insulin that is or is intended to be primarily administered in or through the lungs.
---
2.8 Covenants.
(a) MannKind Non-Compete. During the Term, the Licensors covenant to Sanofi that the Licensors and MannKind Affiliates shall not either themselves or with, for the benefit of, or sponsored by any Third Party, (i) conduct any activity directed to the Development (mutatis mutandis) or registration of a Competing Product in the Territory, (ii) Manufacture a Competing Product that is intended for sale in the Territory, (iii) Commercialize (mutatis mutandis) a Competing Product in the Territory, or (iv) license or authorize, under any MannKind Technology, MannKind Trademarks or Data, any entity other than a MannKind Affiliate to engage in any of the activities described in the preceding clauses (i), (ii) and (iii).
(b) Sanofi Non-Compete. During the Term, Sanofi covenants to the Licensors that Sanofi and its Affiliates shall not either themselves or with, for the benefit of, or sponsored by any Third Party, (i) conduct any activity directed to the Development (mutatis mutandis) or registration of a Competing Product in the Territory, (ii) Manufacture a Competing Product that is intended for sale in the Territory, (iii) Commercialize (mutatis mutandis) a Competing Product in the Territory, or (iv) license, sublicense or authorize, under any MannKind Technology, MannKind Trademarks, Sanofi Technology or Data, any Third Party to engage in any of the activities described in the preceding clauses (i), (ii) and (iii). Notwithstanding the foregoing:
(i) Starting on the fifth (5th) anniversary of the Effective Date, Sanofi may, at its sole cost and expense, Develop (mutatis mutandis) internally at Sanofi or one of its Affiliates a Competing Product generated solely from Sanofi’s or its Affiliate’s internal research efforts; provided, however, that Sanofi and its Affiliates shall not use any MannKind Technology in connection therewith. For the avoidance of doubt, Sanofi shall bear all costs and expenses of Development (mutatis mutandis) of such Competing Product and such costs and expenses shall not be Allowable Expenses and shall not otherwise be subject to EXHIBIT B, except to the extent incurred after the First Commercial Sale of such Competing Product pursuant to approval by the JAC in accordance with the immediately succeeding sentence. The Commercialization (mutatis mutandis) of any such Competing Product during the Term shall require the prior written approval of the JAC. Upon approval by the JAC of such Commercialization, (A) subject to EXHIBIT B, Sanofi shall bear all Commercialization costs and expenses with respect to any such Competing Product, (B) except as expressly set forth below, such Competing Product shall be deemed a “Product” for purposes of Section 6.3 and EXHIBIT B, and (C) payment of Allowable Expenses and calculation and sharing of Profit and Loss with respect to such Competing Product shall be subject to EXHIBIT B; provided, however, that no Development Costs (mutatis mutandis) incurred prior to the First Commercial Sale of such Competing Product shall be included in Allowable Expenses or in the calculation of Profit or Loss.
(ii) Starting on the tenth (10th) anniversary of the Effective Date, Sanofi may in-license or acquire a Competing Product from a Third Party and the Development (mutatis mutandis) and Commercialization (mutatis mutandis) of such in-licensed or acquired Competing Product shall not be governed by the terms of this Agreement. For clarity, Sanofi shall be exclusively responsible for any and all costs and expenses with respect to such Development (mutatis mutandis) and Commercialization (mutatis mutandis) and all costs and expenses with respect to such Development (mutatis mutandis) and Commercialization (mutatis mutandis) and, as between the Parties, shall be entitled to all revenues with respect to such Competing Product.
(c) Acknowledgment. The Parties acknowledge (i) that this Section 2.8 has been negotiated by the Parties, (ii) the geographical and time limitations on activities contained in this Section 2.8 are reasonable, valid and necessary for the adequate protection of the Product business, and (iii) that the Parties would not have entered into this Agreement without the protection afforded by this Section 2.8. Notwithstanding the foregoing, if a court of competent jurisdiction determines that the restrictions set forth in this Section 2.8 are too broad or are otherwise unreasonable under Applicable Law, including with respect to duration, geographic scope, or field, the court is hereby requested and authorized by the Parties to revise the foregoing restrictions to include the maximum restrictions allowable under Applicable Law.
(d) Acquiring Party Business Combination. Neither Party shall be in breach of the provisions of Section 2.8 by reason of its acquisition of a Third Party or its assets or by a Third Party if: (a) within sixty (60) days following the closing of such acquisition, the acquiring Party (or acquiring Third Party) commits in writing to the other Party that such acquirer will promptly divest itself of the Competing Product of such Third Party (whether through sale of business or assets or discontinuation of all activities with respect to the Competing Product); and (b) such divestiture is completed within twelve (12) months after the closing of such acquisition.
|
|
|
Post by wiscdh on Nov 24, 2015 16:53:32 GMT -5
I have United Healthcare and the cost of Afrezza, currently not covered under my plan is $331.96 for a 30-day supply and $905.42 for a 90-day supply. This is all out of pocket.
|
|
|
Post by compound26 on Nov 24, 2015 18:01:31 GMT -5
I have United Healthcare and the cost of Afrezza, currently not covered under my plan is $331.96 for a 30-day supply and $905.42 for a 90-day supply. This is all out of pocket. wiscdh, could you elaborate a little bit so that we understand the TRx and NRx better. If it is not too much information, could you kindly let us know: 1. when were you first prescribed Afrezza; 2. For how many months' supply was the initial prescription; 3. How many refills were included in the initial prescription?
4. How many new prescriptions and refills you have had in total since day one on Afrezza?
5. How many boxes of Afrezza was that price of $331.96 and that price of $905.42 respectively?
If you prefer to PM me your response, that will be great too.
And I welcome others on this board to provide input on the above questions. Or perhaps someone can do a survey on these questions so that we can better interpret the NRx, TRx and refills data.
Many thanks!
|
|
|
Post by peppy on Nov 25, 2015 6:21:29 GMT -5
Thank you so much wiscdh and all that have posted regarding their insurance coverage and costs.
what I would like to see/know is a read of out of the bill from the insurance company health insurance plan. amount paid by the insured? amount paid by the insurance company to settle the bill? = total charge paid? Priceless. Sometimes we are lucky and get to see one of those.
|
|
|
Post by wiscdh on Nov 25, 2015 11:40:35 GMT -5
I am not a diabetic but I wanted to know what the Insurance coverage was in my Health Care Plan. Here is a breakdown on the various costs for Afrezza in my United Healthcare Plan.
POW 4 (60) & 8 (30) Unit 30 day supply is $264.73 90 day supply is $721.27
POW 4 (30) & 8 (60) Unit 30 day supply is $292.13 90 day supply is $796.33
POW 8 & 12 Unit 30 day supply is $331.96 90 day supply is $905.42
POW 4 Unit 30 day supply is $237.30 90 day supply is $646.17
All of this is out of pocket because Afrezza is not covered yet.
|
|
|
Post by peppy on Nov 25, 2015 12:06:35 GMT -5
I am not a diabetic but I wanted to know what the Insurance coverage was in my Health Care Plan. Here is a breakdown on the various costs for Afrezza in my United Healthcare Plan.
POW 4 (60) & 8 (30) Unit 30 day supply is $264.73 90 day supply is $721.27
POW 4 (30) & 8 (60) Unit 30 day supply is $292.13 90 day supply is $796.33
POW 8 & 12 Unit 30 day supply is $331.96 90 day supply is $905.42
POW 4 Unit 30 day supply is $237.30 90 day supply is $646.17
All of this is out of pocket because Afrezza is not covered yet. Thank you. I think what you told me is the not covered my your insurance price for Afrezza, POW 4 (30) & 8 (60) Unit 30 day supply is $292.13 90 day supply is $796.33 Is $3,505 a year if bought 30 day supply. = 11/day $3,200 a 90 day = 10/day
I am going with these numbers now, as I had monthly cost as high as $4,374 a month. $1,114 dollar miss which would have been $12.15 a day.
Apidra $1,406.28 annually apidra $3.90 day.
|
|
|
Post by peppy on Dec 1, 2015 17:58:27 GMT -5
|
|
|
Insurance
Dec 1, 2015 18:18:54 GMT -5
via mobile
Post by jeremg on Dec 1, 2015 18:18:54 GMT -5
Is this representative of UHC as a whole? Edit: So it would seem this is Advantage 3 Tier Plans(?), Afrezza going from Covered to Non-Covered with Humolog as a "cheaper alternative". Now if only people would stop drooling over unsubstantiated "tweets" and do some digging of their own...
|
|
|
Post by dreamboatcruise on Dec 1, 2015 18:27:35 GMT -5
Is this representative of UHC as a whole? No, that would be one particular formulary. UHC has 284 insurance plans, according to formularylookup.com. This particular formulary may apply to several/many of those 284 plans... in particular this could be for a 3 tier Medicare Advantage set of plans but there would be multiple plans within the 284 because of many of them covering only single states or regional sets of states. Latest data on Formularylookup.com shows that of those 284, 59 had Afrezza as covered without restriction (20% of plans by number) but only 7% of UHC patients were within those plans... i.e. likely plans that cost more in premiums and thus have fewer people in them than cheaper plans. Also, it appears that currently there are no UHC Medicare Advantage plans that have Afrezza covered at all, so this 2016 actually doesn't appear to be a change from current situation. Maybe they've never had it covered but since this is the first new year since introduction it earned a spot on this notification of excluded drugs.
|
|
|
Post by jeremg on Dec 1, 2015 18:31:19 GMT -5
Is this representative of UHC as a whole? No, that would be one particular formulary. UHC has 284 insurance plans, according to formularylookup.com. This particular formulary may apply to several/many of those 284 plans... in particular this could be for a 3 tier Medicare Advantage set of plans but there would be multiple plans within the 284 because of many of them covering only single states or regional sets of states. Latest data on Formularylookup.com shows that of those 284, 59 had Afrezza as covered without restriction (20% of plans by number) but only 7% of UHC patients were within those plans... i.e. likely plans that cost more in premiums and thus have fewer people in them than cheaper plans. Any idea how this relates to the now oft cited "tweet" today?
|
|
|
Post by dreamboatcruise on Dec 1, 2015 18:37:06 GMT -5
jeremg... I added one comment above. Nothing I've seen seems to prove that UHC has changed anything for better or for worse, or will be doing so soon. That guy appears to have needed authorization in 2015, had a $45 copay all 2015, and is happy it will still be $45 copay in 2016.
|
|
|
Insurance
Dec 1, 2015 19:01:44 GMT -5
via mobile
Post by boytroy88 on Dec 1, 2015 19:01:44 GMT -5
Someone also tweeted that Costco was selling it at a decent discount from what the other pharmacies are charging without insurance.
Edit: Found the tweet - 90 (4 units) $115.
|
|
|
Post by mnkdnewbie on Dec 1, 2015 19:07:26 GMT -5
Aetna: 8 unit (60) cart w/dev B (brand) N (non-preferred) at walgreens Your Cost: $100.00 (90 for up to 30 days) annual cost $1,216.67
|
|
|
Post by rrtzmd on Dec 1, 2015 19:38:53 GMT -5
Aetna: 8 unit (60) cart w/dev B (brand) N (non-preferred) at walgreens Your Cost: $100.00 (90 for up to 30 days) annual cost $1,216.67 "Afrezza POW 4 (60) & 8 (30) UNIT Not covered" according to the Aetna "rxtools" 2016 formulary lookup site: Aetna 2016 Prescription Drug Search...none of the other combinations were covered either -- at least for my zip code.
|
|