Benzinga | Mar 10, 2021 04:18PM EST

Savara 8-K Shows Co. Entered Master Services Deal With Parexel To Provide Contract Services Related To Clinical Trials Conducted By Co., No Terms Disclosed

On March 5, 2021, Savara Inc. (the "Company") entered into a Master Services Agreement (the "Agreement") with Parexel International (IRL) Limited ("Parexel"), a global contract research organization, pursuant to which Parexel (or its affiliates) will provide contract research services related to clinical trials conducted by the Company in accordance with the terms of separate individual work orders to be entered into by the parties. The effective date of the Agreement is January 6, 2021. Under the Agreement, the Company will pay Parexel for service fees and pass-through expenses incurred by Parexel in accordance with the budget to be set forth in each applicable work order.

The Company may terminate the Agreement and/or any work order without cause on 60 days' prior written notice to Parexel. Either party may immediately terminate the Agreement and/or any individual work order, and Parexel may suspend the performance of services for a material uncured breach by the other party. In addition, either party may immediately terminate the Agreement and/or any individual work order on prior written notice if (i) continuation of the services would pose an undue risk to the health and/or wellbeing of a project participant, (ii) any regulatory certificate, authorization, approval or exemption is revoked, suspended, or expires, (iii) a party reasonably believes continuation of the services would violate applicable law, or (iv) the other party becomes insolvent. Upon expiration and/or termination of the Agreement and/or any work order, the Company will pay Parexel for all service performed, non-cancelable costs and pass-through expenses incurred by Parexel.

Contemporaneously with execution of the Agreement, the Company executed Work Order #1 (the "Work Order") effective January 6, 2021. Under the Work Order, Parexel will provide services related to the Company's IMPALA 2 clinical trial (the "Trial"), a Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 ?g administered once daily by inhalation with matching placebo in patients with autoimmune pulmonary alveolar proteinosis ("aPAP"). As compensation for Parexel's services under the Work Order, the Company will pay Parexel service fees and pass-through expenses according to the project budget, which together are estimated to be approximately $31 million in the aggregate. The parties agreed that services performed by Parexel to date will be governed by the terms and conditions of the Agreement, including the Work Order.