Specification Changes. Upon any change in the Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications (whether initiated by Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise sanofi-aventis in writing of such changes, and sanofi-aventis shall promptly advise Horizon as to any scheduling and/or price adjustments which may result from such changes. Prior to implementation of such changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Product Price for any Product which embodies such changes, (b) any amounts to be reimbursed by Horizon to sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). Horizon shall reimburse sanofi-aventis for the mutually agreed upon reasonable expenses incurred by sanofi-aventis as a result of such changes, including, but not limited to, reimbursing sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs, costs for any Packaging Components or other materials rendered unusable as a result of such changes, and cost of required stability to support a change. If during the Term Horizon amends the Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete quantities of the Active Ingredient, Excipients and/or Packaging Components for the Product on hand at sanofi-aventis, Horizon shall (i) accept the return of all such obsolete Active Ingredient and (ii) purchase from sanofi-aventis, at sanofi-aventis’ Acquisition Cost, all such obsolete Excipients and Packaging Components obtained by sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Product pursuant to Horizon forecasts under Section 6.1. Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of Excipients and Packaging Components corresponding to the immediately following […***…] months of Horizon’s most recent forecasted Pr...
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. If Distributor objects to any Specification change proposed by Supplier, then the parties will consult in good faith to resolve their differences and Supplier will not implement the change without Distributor's consent (not to be unreasonably withheld).
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 effective date of the change. Changes will be coordinated, initial production will be identified and where applicable PPAP’d to the customer. 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 of the 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. If either party desires a change to the Specifications, it shall notify the other party of such desired change and the reasons therefor, including supporting materials, data or reports, if any. The parties agree to negotiate such changes in good faith. If the parties are unable to agree on requested revisions to the Specifications either party may initiate the dispute resolution procedures set forth in Section 15.k; provided, however, that in case of an emergency IQE may make such major process change without prior notice to RFMD if such changes do not impact fit, form or function, but shall notify RFMD of such change promptly thereafter.
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. 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. Upon any change in the Active Ingredient Specifications or Packaging Specifications requested by DANCE (“DANCE Specification Changes”), including the addition of new packaging configurations, DANCE shall promptly advise JULPHAR in writing of any requested DANCE Specification Changes, and JULPHAR shall promptly advise DANCE as to the feasibility of the DANCE Specification Changes, and if in JULPHAR’s reasonably exercised discretion, the DANCE Specification Changes are found to be commercially reasonable and feasible, JULPHAR will inform DANCE of any scheduling and/or price adjustments which may result from the DANCE Specification Changes.
