Progenics/AbbVie:
- Here's a post that goes into detail (plus background) on the royalties.
https://investorshangout.com/post/view?id=5868096
Samsung:
- Posted in March 2019, the initial contract period is from April 1, 2019 to December 31, 2027, encompassing the multitude of potential indications for leronlimab (PRO 140) for which CytoDyn anticipates pursuing regulatory approvals.
- From CytoDyn SEC filings:
https://www.cytodyn.com/investors/sec-filings..._only/6154
American Regent:
- Posted in CytoDyn's 8-K.
https://www.cytodyn.com/investors/sec-filings...223641.pdf
While looking into this I noticed this wording in the 8-K
Does this mean that CytoDyn can distribute/sell via another method/channel in the US without using American Regent...because no BLA will have been approved...but rather an EUA??? Hmmm.....
Don't forget Chiral Pharma in the Philippines:
- Details are scant, but here's the press release:
https://www.cytodyn.com/newsroom/press-releas...nlimab-for
- Here's a post that goes into detail (plus background) on the royalties.
https://investorshangout.com/post/view?id=5868096
Samsung:
- Posted in March 2019, the initial contract period is from April 1, 2019 to December 31, 2027, encompassing the multitude of potential indications for leronlimab (PRO 140) for which CytoDyn anticipates pursuing regulatory approvals.
- From CytoDyn SEC filings:
https://www.cytodyn.com/investors/sec-filings..._only/6154
Quote:During the fourth quarter of fiscal 2019, the Company entered into a Master Services Agreement and Product Specific Agreement (collectively, the “Samsung Agreement”) with Samsung BioLogics Co., Ltd. (“Samsung”), pursuant to which Samsung will perform technology transfer, process validation, manufacturing and supply services for the commercial supply of leronlimab. As of quarter ended August 31, 2020, the Company delivered to Samsung purchase orders totaling approximately $45 million related to the manufacture of leronlimab and payments totaling $34 million, with additional payments scheduled to be made throughout calendar 2020. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the full amount of the purchase order. Under the terms of the Samsung Agreement, the Company is obligated to make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which the Company is required to provide to Samsung. The first forecast schedules 11 manufacturing batches, all beginning in the quarter ended August 31, 2020 , setting forth the total quantity of commercial grade leronlimab the Company expects to require in the following years. The Company estimates initial ramp-up costs to manufacture commercial grade leronlimab at scale could total approximately $112 million, with approximately $65 million payable over the course of calendar 2020, of which $37 million has been paid as of the date of this filing, and approximately $24 million payable during calendar 2021, and approximately $23 million payable in January of 2022. Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement. The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional two-year periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the other party’s insolvency or uncured material breach, and the Company may terminate the agreement in the event of a voluntary or involuntary complete market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.
On May 22, 2020, the Company entered into a Drug Product Manufacturing Services Agreement with Samsung (the “Samsung Vial Filling Agreement”), pursuant to which Samsung will perform technology transfer, process validation, vial filling and storage services for clinical, pre-approval inspection, and commercial supply of leronlimab. Under the terms of the Samsung Vial Filling Agreement, the Company is obligated to have specified minimum quantities of vials filed with leronlimab by Samsung pursuant to forecasted requirements which the Company is required to provide to Samsung. The Company has not provided a forecast to Samsung, however based on set-up related costs and manufacturing commitments pursuant to the Samsung Agreement the Company expects to deliver commitments of approximately $2.6 million in the form of purchase orders related to the Samsung Vial Filling Agreement through January 2021.
American Regent:
- Posted in CytoDyn's 8-K.
https://www.cytodyn.com/investors/sec-filings...223641.pdf
While looking into this I noticed this wording in the 8-K
Quote:2.1 American Regent Distribution in the Field.
(a) Upon and subject to the terms and conditions of this Agreement, and upon FDA approval of the BLA for the Product in the Field, CytoDyn hereby appoints American Regent as the sole and exclusive authorized distributor in the Field in the Territory, with the right to subcontract to its subcontractors, to sell and distribute the Product in the Field in the Territory.
Does this mean that CytoDyn can distribute/sell via another method/channel in the US without using American Regent...because no BLA will have been approved...but rather an EUA??? Hmmm.....
Don't forget Chiral Pharma in the Philippines:
- Details are scant, but here's the press release:
https://www.cytodyn.com/newsroom/press-releas...nlimab-for
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