Specification Changes. All Product shall be produced in accordance with the procedures set forth in the Batch Record attached as Exhibit C and amended from time to time and all Product shall meet the applicable Specifications set forth solely in Exhibit B as of the date of manufacturing at Xxxxxx. Xxxxxx shall perform all analytical and in-process testing necessary to show conformity to the Specifications set forth in Exhibit B. If Abbott is unable to perform all such services, the fee payable to Abbott shall be reduced by [*****]. Abbott shall provide [*****] prior notice of any intended change to equipment that Abbott is aware will be, or was listed in, the NDA filed by Scios for the Product. Abbott shall without additional charge assist Scios in preparing any submission of information and/or conducting any validation required to obtain FDA approval for such change of equipment. Abbott shall at its cost be responsible for the completion of any validation required in connection with obtaining FDA approval for the equipment change. No modification in the control documents (as defined in 21 C.F.R. Part 211.186) relating to the manufacturing procedure, quality assurance/control procedures or procedures to assure compliance with the Specifications shall be made without Scios’ prior written approval. Scios shall have the right to modify the Specifications (Exhibit B) and Batch Record (Exhibit C) from time to time. Any change made shall apply only to production batches produced after changes are accepted by Abbott. If Scios notifies Abbott of a proposed modification, Abbott shall advise Scios within [*****] whether the modification is feasible and if it is, the estimated changes, if any, in the costs, delivery time or other terms which would result from such modification. Notwithstanding the foregoing, the modification shall be implemented by Abbott only upon Xxxxxx’x reasonable consent and specific written authorization by Scios after receipt of such estimate and agreement on appropriate modifications to Exhibit B or Exhibit X. Xxxxxx shall notify Scios of equipment and/or facility changes that might effect any Scios filing with the FDA, providing Abbott is aware of said filing. Abbott and Scios shall work together to prepare regulatory filings or amendments on said equipment and/or fileable changes.
Specification Changes. (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.
Specification Changes. Supplier reserves the right to change the Specifications by written notice to Distributor.
Specification Changes. Changes to specifications are made by mutual agreement between the Supplier and the Customer. In addition to agreement of the change, the Supplier and Customer will determine the effectivity date of the change. When the specifications include references to brand names, the Supplier and Customer will mutually agree on the implementation of any changes made in the brand name product.
Specification Changes. In the event Seller incurs additional expense because of changes in specifications or drawings previously approved by Buyer, or in the event Seller is required to modify the ordered Equipment, perform any additional work or supply any additional Equipment or Parts, the additional expense shall be added to the purchase price. Seller shall have the right, in its sole discretion, to accept or reject any changes in specifications requested by Buyer. In no event shall any changes in specifications be made or accepted thirty (30) days prior to launch date or thereafter.
Specification Changes. SMI shall not make any change to the Modified Starch (including materials, packaging, and directions for use), Modified Starch Specifications, the raw materials, suppliers of starch, manufacturing process for the Modified Starch or the Products Specifications (collectively, “Specification Changes”), unless approved by CryoLife in writing in advance, which approval may not be unreasonably denied (with the Parties understanding that any such changes that would require new, or change to any Regulatory Approval may be denied by CryoLife due to the cost or time involved in that change).
Specification Changes. FIBERSTARS and VLI anticipate that it may be desirable during the term of this Agreement to amend the Product Specifications. Such amendments to the Product Specifications shall be made by mutual agreement of VLI and FIBERSTARS. If such Product Specification changes require or allow a change in pricing, such pricing changes shall be by mutual agreement and shall be reflected in a revision to Exhibit C pursuant to an amendment to this Agreement.
Specification Changes. 5.1 Pursuant to the terms contained in this Xxxxxxxxx 0, Xxxxxxxxx may chose to cancel certain SCNs listed in Exhibit B to the Agreement. The SCNs that may be so cancelled and applicable leadtimes for cancellation are listed in Appendix 2 hereto (the "Cancelable SCN(s)").
Specification Changes. Supplier shall have the right to make changes to the Specifications from time to time, and shall notify Customer thereof in advance no less than three (3) months prior to the first delivery to Customer of API implementing such change(s). Supplier shall first obtain Customer’s prior written consent to any such change (other than a change required by a Regulatory Authority) that would affect Customer’s then pending Regulatory Filing(s) or in-process pre-marketing clinical trial for a Recro Product. Following grant of Regulatory Approval, Supplier shall first obtain Customer’s prior written consent to any such changes (other than a change required by a Regulatory Authority) that would affect Customer’s Regulatory Approval(s), such consent not to be unreasonably withheld. Customer recognizes that change may be necessary to enable Supplier to remain efficient and cost-effective and thus shall be fully supportive of the implementation of such changes where justified.
Specification Changes. Netrx xx Supplier may, from time to time, request changes to the Products shown in Appendix "A" by delivering to the other party a fully approved Engineering Change Order (ECO) or reasonable facsimile as used by Supplier's internal documentation system. Sufficient documentation will be included in the change, to effectively support an investigation of the impact of the engineering change. The proposed change will be fully evaluated within ten (10) working days of receipt and an effective change date shall be mutually agreed to by Netrx xxx Supplier. Any ECO changes deemed to be "Critical" by either Netrx xx Supplier shall be immediately brought to the attention of the other party, by written notification, and such ECO changes will be mutually evaluated and completed within two (2) working days of such notification. If any such implemented change causes an increase or decrease in the price of, or time required for the delivery of material or performance of work under this Agreement, an equitable adjustment shall be made in the Contract Price and/or the delivery dates. Netrx xxx final design approval on all Products, changes to Products, and modifications to Products.
