XML 42 R23.htm IDEA: XBRL DOCUMENT v3.20.4
Subsequent Events
12 Months Ended
Dec. 31, 2020
Subsequent Events [Abstract]  
Subsequent Events Subsequent Events
In March 2021, the Company entered into a supply agreement (the "BioVectra Agreement") with BioVectra Inc. ("BioVectra") for the manufacture and supply by BioVectra of bulk drug substance for bentracimab, for commercial distribution following regulatory approval, if obtained. Under the terms of the BioVectra Agreement, BioVectra has committed to maintaining capacity to manufacture an agreed number of batches of product each year, and the Company has committed to purchase a specified minimum number of batches of product per year (the "Minimum Annual Commitment"), although the Company is free to contract with third parties for the manufacture of bentracimab.
The Company will pay a supply price per batch of product to be determined after the manufacturing process for the product is validated in accordance with the BioVectra Agreement, plus the cost of certain consumables, raw materials, and third-party testing. The parties have agreed that the initial supply price of product will be within a specified percentage of the estimated supply price set forth in the BioVectra Agreement and will remain firm through the second anniversary of validation. Thereafter, on an annual basis following the second anniversary of validation, either party may propose adjustments to the supply price for increases or decreases based on a specified inflation rate, subject to a maximum inflation adjustment per year, and BioVectra may propose adjusting the supply price beyond that inflation rate if it can document extraordinary increases or decreases in costs, subject to a specified maximum percentage increase or decrease per year.
Pursuant to the Minimum Annual Commitments, the Company is obligated to purchase a minimum of (i) approximately $14.0 million of batches of product in years 2022 through 2023, (ii) approximately $37.0 million of batches of product in 2024, and (iii) approximately $48.0 million of batches of product in each of years 2025 through 2031. In the event the Company does not purchase the applicable Minimum Annual Commitment in a given year, the Company will be obligated to make a payment to BioVectra in an amount equal to the then-applicable supply price per batch multiplied by the difference between the Minimum Annual Commitment for such year and the number of batches of product the Company actually purchased in such year (the “Minimum Shortfall Payment”), except in the event that BioVectra was unable to deliver the number of batches ordered by the Company in such year. In the event of certain serious or extended failures by BioVectra to supply product in the quantities ordered by the Company in a given year, the Company’s Minimum Annual Commitment for such year (and potentially one or more subsequent years) will be subject to reduction, and the Company’s obligation to make a Minimum Shortfall Payment for such year (and potentially one or more subsequent years) will be waived. The Company will have the right to reduce the Minimum Annual Commitments for the year 2026 and subsequent years by up to a specified maximum percentage per year. Further, if the Company is only able to obtain regulatory approval for products incorporating bentracimab in only one of the U.S. or Europe, BioVectra and the Company have agreed to discuss in good faith an amendment to the Agreement to reflect decreased requirements for product and impacts to the supply price to reflect lower volume commitments.
The initial term of the BioVectra Agreement commences on the effective date of the BioVectra Agreement and continues until the tenth anniversary of validation. The term of the BioVectra Agreement may be extended for additional one-year periods upon mutual agreement of the parties. Either party may terminate the BioVectra Agreement in the event of an uncured material breach by the other party or upon the occurrence of certain events of insolvency of the other party. The Company may terminate the BioVectra Agreement (i) in the event of certain regulatory compliance failures by BioVectra or any person employed or retained by it to perform services under the BioVectra Agreement, or (ii) subject to payment of a termination fee to BioVectra (the amount of which decreases over the term of the BioVectra Agreement from an initial maximum in the mid-teens of millions of dollars to zero), in the event the Company decides that it will not, or is unable to, pursue regulatory approval or commercialization of products incorporating bentracimab or in the event of termination of the Company’s license to bentracimab from MedImmune Limited. The Company may also terminate the BioVectra Agreement without cause and without payment of a termination fee upon 24 months’ notice following the fifth anniversary of regulatory approval of a product incorporating bentracimab by either the FDA or EMA.