Process Improvements. The Parties agree that during the course of the Agreement, the Parties may identify and implement process improvements that can benefit both Parties. If one of the Parties identifies an opportunity for improvements related to raw materials, such Party will notify the other Party and the Parties will jointly discuss and use good faith efforts to agree to these opportunities. Any cost-related improvements resulting from these projects will be shared across both Parties, with [***] of the cost savings being passed through to Sponsor. Such improvements must be within the validated parameters of the process and shall not be effective unless mutually agreed in writing by the Parties and approved by relevant regulatory authorities.
Process Improvements. The parties acknowledge that CPL may develop improvements to the manufacturing process or procedure in the course of performing the Services under this Agreement (“Process Improvements”). CPL agrees to promptly disclose all Process Improvements to Helix as they occur.
Process Improvements. As required by 21 CFR Part 820 Sec. 820.50, Supplier shall not make significant changes to the Specifications, manufacturing process, tooling design, processing conditions, materials or manufacturing location of the Products without SI-BONE’s prior written consent. Notwithstanding the foregoing, SI-BONE will consider in good faith reasonable written requests by Supplier to change the materials or manufacturing process of the Products, provided SI-BONE shall make final determination on such change(s) in its sole discretion.
Process Improvements. The parties acknowledge that BioVectra may develop improvements to the Master Formula or procedure in the course of performing the Services under this Agreement (“Process Improvements”). BioVectra agrees to promptly disclose all Process Improvements to Helix as they occur.
Process Improvements. Following Facility Approval, ACSD may continue operating [*] with the [*]. Development undertaken for the purpose of [*] will be [*]. ACSD will [*]. All modifications in raw materials, conditions or processing related to the manufacture of Product will be implemented [*]. The [*] following a successful and complete cGMP change control process outlined in the [*].
Process Improvements. The Doctors of BC and WorkSafeBC recognize a number of issues that would increase the ease and efficiency of the delivery of Physician Services to Injured Workers. The parties recognize that some of the items are dependent on third party assistance and co- operation in whole or in part, and may involve significant costs/resources, and as a result, the contemplated actions or resolutions may not be achievable. The parties also recognize that the ability to proceed with any particular items, and the speed at which it can be accomplished, is subject to resourcing, financial and business capacities.
Process Improvements. During the Term of this Agreement, the Parties shall work together to improve the manufacturing process for the Product including the following areas, among other items, communication, batch yield, design improvements, stability, quality controls, cycle time, on-time delivery and reducing costs for the manufacture of Product. To that effect, representatives of the Parties shall meet at least every [***] during the first [***] months of the Term of this Agreement and thereafter not less than once every year to discuss improvements and how to implement such improvements.
Process Improvements. The Parties currently envisage to improve the manufacturing process for the Products in order to reduce processing times resulting in an increased output of Batches per calendar week. If the Parties mutually agree that the currently envisaged improved process has been successfully established at APCETH’s Facility, (i) [***], and (ii) [***].
Process Improvements. The Parties acknowledge that Solvay or COR may develop or acquire improvements to the manufacturing materials, equipment, procedure, Solvay Know-how or Licensed Process in the course of fulfilling its obligations under this Agreement and the Supply Agreement. Solvay agrees to obtain COR's consent prior to implementing such improvements, or any changes in the Licensed Process or [*]. Any such improvements developed or acquired by Solvay which are used commercially by Solvay or the Secondary Source and/or Back-up Secondary Source for making bulk peptide products containing Integrelin shall be deemed to be within the definition of Licensed Process or Solvay Know-how as licensed in Section 3.1. Except as provided below, COR hereby agrees to establish only a Secondary Source (and/or Back-up Secondary Source) which agrees to grant back to COR a non-exclusive, worldwide, royalty-free license, sublicenseable by COR to entities entitled to practice the Licensed Process, to use any improvements to the manufacturing materials, equipment, procedure, Solvay Know-how or the Licensed Process related to this Agreement which are developed or acquired by such Secondary Source, to develop, use, sell, have sold, [*] or have manufactured by the Secondary Source (and/or Back-up Secondary Source) [*] of this Agreement, Integrelin and products containing Integrelin. COR hereby agrees to sublicense the rights granted to it pursuant to this Section 3.3 by a Secondary Source (and/or Back-up Secondary Source) to Solvay, for use by Solvay during any time period wherein Solvay is supplying COR with Bulk Product, pursuant to the terms of any supply arrangement between COR and Solvay. COR agrees that it will use any such Secondary Source improvements to
Process Improvements a) [*] agrees to communicate to [*] any idea and substantial improvement made by [*] arising from [*] under the following conditions: (i) all rights and title to improvements (patented or unpatentable) which are related to the [*] shall be assigned to [*] which shall have only the right to utilize such improvements in the manufacture of the Product; (ii) all rights and title to improvements (patented or unpatentable) which apply to the [*] and provided that [*] is not contained in said improvements, shall be assigned to [*] which shall have only the right to utilize such improvements in the process of the Product; (iii) a royalty-free worldwide exclusive license [*] shall be granted by [*] to [*] for improvements (patented or unpatentable) related to said processing [*] (iv) in the event that [*] contracts out the manufacture of the Product to any third party, any improvement made by [*] hereunder may be disclosed to such contract manufacturer but rights to use the same shall be restricted to the manufacture of the Product and the Parties hereto will [*].
