Common use of Specification Changes Clause in Contracts

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. (b) Either Party may request a Specifications change intended to maintain high standards but that are not required for compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes shall be made only with the Parties' mutual consent. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval of such Specification change shall not be unreasonably withheld; provided, however, if there are two or more alternatives for complying with the change in Regulatory Acts and Applicable Laws, each of which GSK believes, in its sole discretion, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus shall have the right to choose which of such alternatives shall be implemented. The costs for changes to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(g), as applicable. (c) GSK shall not make any revisions to the Specifications without prior written consent of Prometheus in accordance with the Quality Agreement. All requests by GSK for such revisions shall be submitted in writing to Prometheus on the forms included in the Quality Agreement. (d) (i) General. From time to time Prometheus or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be a requirement resulting from cGMPs changes. Responsibility for the cost of all such labeling or artwork changes under this Section 4.2(d) shall be borne as described in Section 3.1.

Specification Changes. 5.5.1 In the event Barrier changes the Specifications, Barrier shall promptly advise DSM in writing of such changes, and in the event that such changes directly impact DSM’s scheduling or costs, DSM shall promptly advise Barrier as to any scheduling and/or price adjustments caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith in an attempt to reach agreement on (a) During the Termnew price for any Product which embodies such changes, GSK will accept a labeling change from Prometheus as contemplated , and any other amendments to this Agreement which may be necessitated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material such changes (such as packaging designi.e., manufacturing process or similar or related changes) an adjustment to the existing Product lead time for purchase orders). 5.5.2 Barrier agrees to reimburse DSM for the reasonable expenses incurred by DSM as a result of such changes, including, but not limited to, reimbursing DSM for its validation and development costs, capital expenditure costs and costs for any packaging components or other materials rendered unusable as a result of such changes which were reasonably purchased or incurred in reliance on Barrier’s forecasts; provided, in each case that DSM is not able to utilize any such equipment or materials for its other customers. 5.5.3 If during the Term. term of this Agreement Barrier amends or is required by law to amend the Specifications so as to render the Active Pharmaceutical Ingredients, Excipients and/or packaging components for the Product obsolete, Barrier shall (a) at Barrier’s option, purchase from DSM, at DSM’s Acquisition Cost, that amount of inventory of Excipients and packaging components so rendered obsolete, or (b) Either Party may request a Specifications change intended to maintain high standards but that are not required for compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes shall be made only with the Parties' mutual consent. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval accept DSM’s return of such Specification change materials to Barrier and reimburse DSM any restocking fees incurred; and Barrier shall not be unreasonably withheld; providedalso purchase from DSM, howeverat the applicable Product Price, if there are two that amount of inventory of Product which is rendered obsolete. In addition to reimbursement of DSM’s Acquisition Cost for obsolete inventories, Barrier shall also *** for *** the *** or more alternatives for complying with the change in Regulatory Acts and Applicable Laws, each ***of which GSK believes, in its sole discretion, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus shall have the right to choose which of such alternatives shall be implemented. The costs for changes to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(g), as applicable***. (c) GSK 5.5.4 DSM shall not make any revisions change to the Specifications without Barrier’s prior written consent of Prometheus in accordance with the Quality Agreement. All requests by GSK for such revisions shall be submitted in writing to Prometheus on the forms included in the Quality Agreementconsent. (d) (i) General. From time to time Prometheus or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be a requirement resulting from cGMPs changes. Responsibility for the cost of all such labeling or artwork changes under this Section 4.2(d) shall be borne as described in Section 3.1.

Specification Changes. (a) During All Product shall be produced in accordance with the Term, GSK will accept a labeling change procedures set forth in the Batch Record attached as Exhibit C and amended from Prometheus time to time and all Product shall meet the applicable Specifications set forth solely in Exhibit B as contemplated by this Section 4.2 but otherwise of the Parties acknowledge date of manufacturing at Xxxxxx. Xxxxxx shall perform all analytical and agree that GSK does not intend in-process testing necessary to make any material changes (such as packaging design, manufacturing process or similar or related changes) show conformity to the existing Product during Specifications set forth in Exhibit B. If Abbott is unable to perform all such services, the Term. 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 (bas defined in 21 C.F.R. Part 211.186) Either Party may request a Specifications change intended relating to maintain high standards but that are not required for the manufacturing procedure, quality assurance/control procedures or procedures to assure compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes Specifications shall be made only with the Parties' mutual consentwithout Scios’ prior written approval. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval of such Specification change shall not be unreasonably withheld; provided, however, if there are two or more alternatives for complying with the change in Regulatory Acts and Applicable Laws, each of which GSK believes, in its sole discretion, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus Scios shall have the right to choose 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 alternatives estimate and agreement on appropriate modifications to Exhibit B or Exhibit X. Xxxxxx shall be implemented. The costs for notify Scios of equipment and/or facility changes to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(g), as applicable. (c) GSK shall not make that might effect any revisions to the Specifications without prior written consent of Prometheus in accordance Scios filing with the Quality AgreementFDA, providing Abbott is aware of said filing. All requests by GSK for such revisions Abbott and Scios shall be submitted in writing work together to Prometheus prepare regulatory filings or amendments on the forms included in the Quality Agreementsaid equipment and/or fileable changes. (d) (i) General. From time to time Prometheus or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be a requirement resulting from cGMPs changes. Responsibility for the cost of all such labeling or artwork changes under this Section 4.2(d) shall be borne as described in Section 3.1.

Specification Changes. 5.6.1. OMEROS may amend the Specifications, the API Specifications or specifications for Excipients: (a) During unilaterally and in its sole discretion for the Termpurpose of complying with any Product Approval, 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 designApplicable Pharmaceutical Law or other Applicable Law, manufacturing process or similar or related changes) to the existing Product during the Term. (b) Either Party may request a Specifications change intended to maintain high standards but that are not required for compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes shall be made only with the Parties' mutual consent. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval of such Specification change shall not be unreasonably withheld; provided, however, that if there are two DSM reasonably determines that it is incapable for technical reasons of compliance with such amended Specifications, API Specifications or more alternatives specifications for complying with the change in Regulatory Acts and Applicable Laws, each of which GSK believes, in its sole discretionExcipients, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus shall promptly so notify OMEROS and OMEROS shall have the right at its discretion to choose terminate this Agreement as to the affected Product or (b) for any other reason upon commercially reasonable prior written notice (which shall not be interpreted to require in excess of [†] days’ prior notice before implementation of the amendment) and subject to DSM’s approval, such approval not to be unreasonably withheld. OMEROS shall promptly advise DSM in writing of such alternatives changes; and if such changes directly impact DSM’s scheduling or costs, DSM shall promptly advise OMEROS as to any scheduling adjustments and/or cost increases for DSM caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith in an attempt to reach agreement on (a) the new price for any Product which embodies such changes, reflecting any increases or decreases to DSM in the cost or quantities of materials consumed, provided that the change in price shall directly reflect any changes on DSM’s costs in Manufacturing the Product (other than any such costs addressed in Section 5.6.2), and (b) any other amendments to this Agreement that may be implemented. The costs for necessitated by such changes (e.g., an adjustment to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(glead time for Purchase Orders), as applicable. (c) GSK shall . DSM may not make any revisions to modify or amend the Specifications or the Manufacturing process, or change the site at which Manufacturing activities are performed hereunder, without the prior written consent of Prometheus in accordance with the Quality Agreement. All requests by GSK for such revisions shall be submitted in writing to Prometheus on the forms included in the Quality AgreementOMEROS. (d) (i) General5.6.2. From time OMEROS agrees to time Prometheus reimburse DSM for the reasonable expenses incurred by DSM as a result of the changes referenced in Section 5.6.1, including, but not limited to, reimbursing DSM for its validation and development costs, capital expenditure costs and costs for any packaging components or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be other materials rendered unusable as a requirement resulting from cGMPs result of such changes. Responsibility † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION 5.6.3. If during the Term OMEROS amends or is required by law to amend the Specifications, the API Specifications or specifications for Excipients so as to render the cost Active Pharmaceutical Ingredients, Excipients and/or packaging components for any Product obsolete, OMEROS shall reimburse DSM, at DSM’s Acquisition Cost, for any such inventory, reasonably acquired by DSM in reliance upon this Agreement, rendered obsolete. DSM shall ship to OMEROS or OMEROS’ designee or destroy, at OMEROS’ sole election and expense, such obsolete inventory. In addition to reimbursement of all DSM’s Acquisition Cost and the costs of any shipment or destruction of such labeling or artwork changes under this Section 4.2(d) inventories, OMEROS shall be borne as described in Section 3.1pay DSM [†].

Specification Changes. (a) During All Product shall be produced in accordance with the Term, GSK will accept a labeling change procedures set forth in the Batch Record attached as Exhibit C and amended from Prometheus time to time and all Product shall meet the applicable Specifications set forth solely in Exhibit B as contemplated by this Section 4.2 but otherwise of the Parties acknowledge date of manufacturing at Xxxxxx. Xxxxxx shall perform all analytical and agree that GSK does not intend in-process testing necessary to make any material changes (such as packaging design, manufacturing process or similar or related changes) show conformity to the existing Product during Specifications set forth in Exhibit B. If Abbott is unable to perform all such services, the Term. 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 (bas defined in 21 C.F.R. Part 211.186) Either Party may request a Specifications change intended relating to maintain high standards but that are not required for the manufacturing procedure, quality assurance/control procedures or procedures to assure compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes Specifications shall be made only with the Partieswithout Scios' mutual consentprior written approval. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval of such Specification change shall not be unreasonably withheld; provided, however, if there are two or more alternatives for complying with the change in Regulatory Acts and Applicable Laws, each of which GSK believes, in its sole discretion, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus Scios shall have the right to choose 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 alternatives estimate and agreement on appropriate modifications to Exhibit B or Exhibit X. Xxxxxx shall be implemented. The costs for notify Scios of equipment and/or facility changes to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(g), as applicable. (c) GSK shall not make that might effect any revisions to the Specifications without prior written consent of Prometheus in accordance Scios filing with the Quality AgreementFDA, providing Abbott is aware of said filing. All requests by GSK for such revisions Abbott and Scios shall be submitted in writing work together to Prometheus prepare regulatory filings or amendments on the forms included in the Quality Agreementsaid equipment and/or fileable changes. (d) (i) General. From time to time Prometheus or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be a requirement resulting from cGMPs changes. Responsibility for the cost of all such labeling or artwork changes under this Section 4.2(d) shall be borne as described in Section 3.1.