The initial expiration date of the Offer is one minute following 11:59 p.m., Eastern Time, on February 21, 2023, subject to extension in certain circumstances as permitted by the Merger Agreement (the “Expiration Date”).
CVR Agreement
The summary of the material provisions of the CVR Agreement contained in Section 11 (Summary of the Merger Agreement and Certain Other Agreements) and the description of the conditions to the Offer contained in Section 13 (Conditions of the Offer) of the Offer to Purchase are incorporated herein by reference. Such summary and description are qualified in their entirety by reference to the Form of Contingent Value Rights Agreement, which is filed as Exhibit (e)(2) hereto and is incorporated herein by reference.
As promptly as practicable after the date of the Merger Agreement and, in any event, at or prior to the Effective Time, Ipsen will authorize and duly adopt, execute and deliver, and will ensure that a duly qualified rights agent (“Rights Agent”) executes and delivers, the CVR Agreement, subject to any reasonable revisions to the CVR Agreement that are requested by such Rights Agent (provided, that such revisions are not, individually or in the aggregate, detrimental or adverse to any holder of a CVR).
Each CVR represents the non-tradeable contractual right to receive a contingent one-time payment in cash of up to $10.00 per Share, payable to the Rights Agent for the benefit of the holder of such CVR, in each case without interest and less any required withholding taxes (the “Milestone Payment”), payable as specified upon the achievement of the following milestone (the “Milestone”) prior to December 31, 2027 (such period, the “Milestone Period”): the final approval by the U.S. Food and Drug Administration (“FDA”) of the new drug application or supplemental new drug application filed with the FDA pursuant to 21 U.S.C § 355(b) that is necessary for the commercial marketing and sale of odevixibat in the United States for the treatment of biliary atresia in patients, for which approval the FDA did not require any studies or clinical trials in addition to A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (NCT04336722, Study A4250-011 (BOLD)) and its open label extension study, An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia (NCT05426733, Study A4250-016 (BOLD-EXT)) (the “BOLD Study”).
The CVR Agreement requires Ipsen to use those commercially reasonable efforts that are at least commensurate with the level of efforts that a pharmaceutical company of comparable size and resources as those of Ipsen and its affiliates would devote to the development and seeking of regulatory approval for a pharmaceutical product having similar market potential as odevixibat, also known as A4250 and marketed under the brand name Bylvay, at a similar stage of its development or product life, taking into account its safety, tolerability and efficacy, its proprietary position and profitability (including pricing and reimbursement status, but excluding the obligation to pay the Milestone Payment Amounts under the CVR Agreement), projected costs to develop such product, the competitiveness of alternative third party products, the patent and other proprietary position, including regulatory exclusivities, of such product, and the regulatory environment and other relevant technical, commercial, legal, scientific and/or medical factors to achieve the Milestone prior to the end of the Milestone Period; provided, that it is understood that the number of subjects in the BOLD Study will be increased and such increase, and any actions and changes reasonably required in connection with such increase, shall not be deemed to be a violation of the CVR Agreement.
The right to the payment described above is solely a contractual right governed by the terms and conditions of the CVR Agreement. The CVRs will not be evidenced by a certificate or other instrument, will not have any voting or dividend rights and will not represent any equity or ownership interest in Ipsen, Purchaser, Albireo, Guarantor or any of their respective subsidiaries or affiliates. The CVRs will not be registered or listed for trading. No interest will accrue or be payable in respect of any of the amounts that may be payable on CVRs. Holders of CVRs will have no greater rights against Ipsen than those accorded to general, unsecured creditors under applicable law.
The CVR Agreement provides that the holders of CVRs are intended third party beneficiaries of the CVR Agreement.
The CVRs will not be transferable except (a) upon death of a holder by will or intestacy; (b) by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (c) pursuant to a court order; (d) by operation of law (including by consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (e) in the case of CVRs payable to a nominee, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in each case to the extent as allowable by The Depository Trust Company; or (f) to Ipsen or any of its affiliates in connection with the abandonment of such CVR by the applicable holder.
Under the CVR Agreement, Guarantor irrevocably and unconditionally guarantees to the Rights Agent the full and timely performance and satisfaction of Ipsen’s obligations as set forth in the CVR Agreement, in each case as and when due. If, for any reason whatsoever, Ipsen fails or is unable to make full and timely payment as set forth in the CVR Agreement or perform any of its obligations under the CVR Agreement, such payment or obligations will be due and payable for the purposes thereof, and Guarantor will forthwith pay and cause to be paid in lawful currency of the United States, or perform or cause to be performed, Ipsen’s obligations thereunder.
Ipsen must keep records in sufficient detail to determine compliance with the terms of the CVR Agreement.
The Milestone may only be achieved once. If the Milestone is not achieved prior to December 31, 2027, holders of Shares will receive only the Closing Amount for any Shares tendered in the Offer and no payment with respect to the CVRs. It is not possible to predict whether any payment will become payable with respect to the CVRs. Whether the Milestone required for payment of the Milestone Payment is met will depend on many factors, some of which are outside the control of Albireo, Ipsen and their respective affiliates. There can be no assurance that the Milestone will be achieved or that any payment with respect to the CVRs will be made.
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