Common use of Change Notice Clause in Contracts

Change Notice. 7.1.1. The parties hereby acknowledge and agree that in the event that: (i) during the Technology Transfer Period, changes are proposed or required, including, without limitation, changes to any activities and/or deliverables set out in Schedule A, changes to Schedule F and/or process changes; (ii) beginning in Manufacturing Year 1, at the end of each Manufacturing Year the actual Batch size varies from Schedule B for that Manufacturing Year; or (iii) there is a change in, or proposed change to, the Amikacin, ARIKACE Specifications, Master Batch Records, ARIKACE SOPs, the Manufacturing of ARIKACE and/or the Commercial Manufacturing Date, then this Agreement and the applicable Schedule shall be amended in accordance with the procedure described below. 7.1.2. Either party shall present a written notice to the other party outlining in sufficient detail the proposed changes to the relevant Schedule (the “Change Notice”). 7.1.3. Within [***] Business Days after submission of the Change Notice, Therapure shall present in writing to Insmed a quote for work to be undertaken and/or proposed revisions to the Batch Processing Fee (the “Change Fee”), required as a result of the Change Notice, such Change Fee to reflect solely the incremental costs and Therapure’s reasonable profits associated with the Change Notice, as supported by reasonable documentation provided by Therapure to Insmed. 7.1.4. The parties shall have [***] Business Days (the “Review Period”) after presentation of the Change Fee to discuss the Change Fee. On or before the expiry of the Review Period, the parties shall: (i) accept the Change Fee by executing the Change Fee and related Change Notice (in accordance with Section 7.1.6) and returning a copy to each other; (ii) discuss proposed amendments to the Change Fee and/or related Change Notice; or (iii) reject the Change Fee in writing (in which case the Change Fee and related Change Notice shall not be effective). 7.1.5. Any amended Change Fee and/or related Change Notice mutually agreed and executed by the parties shall be incorporated as part of the relevant Schedule and such Schedule shall be deemed to have been amended to include the Change Fee and/or related Change Notice, as amended. 7.1.6. All Change Fees and related Change Notices will be executed (i) on behalf of Therapure by its Vice President, Operations and (ii) on behalf of Insmed by its Vice-President, Technical Operations before they will be deemed to be effective. In addition, Change Fees and related Change Notices that include changes in the Batch Processing Fees will also be executed (i) on behalf of Therapure by its Chief Executive Officer; and (ii) on behalf of Insmed by its Vice-President, Technical Operations before they will be deemed to be effective. 7.1.7. The parties acknowledge and agree that changes in Schedule A, Schedule B, or Schedule F may result in changes to the pricing set out in this Agreement. If any Change Notice may result in documented changes to the pricing set out in this Agreement, the parties shall negotiate an appropriate amendment to this Agreement to reflect such changes, applied retroactively to the effective date of such changes.

Change Notice. 7.1.1OWNER may, at any time, initiate a Change Order by causing a Change Notice to be issued to the Contractor. The parties hereby acknowledge and agree that A Change Notice shall be the standard method employed to notify the Contractor of OWNER’s intent to implement a Change Order. A Change Notice will indicate one of the following: .1 That the proposed Change Order involves no adjustment of the Contract Price or the Contract Time; .2 That the proposed Change Order involves only items for which there are changes in quantities of items for which unit prices are specified in the event that: (i) during the Technology Transfer Period, changes are proposed or required, including, without limitation, changes to any activities and/or deliverables set out in Schedule A, changes to Schedule F and/or process changesContract Documents; (ii) beginning in Manufacturing Year 1.3 That the proposed Change Order involves an adjustment of the Contract Price or the Contract Time, at and the end of each Manufacturing Year Change Notice proposes the actual Batch size varies from Schedule B basis for that Manufacturing Yearadjusting the schedule or the compensation, or both; or (iii) there is .4 That the proposed Change Order may involve an adjustment in the Contract Price or the Contract Time and will require that the Contractor submit a change in, or proposed change to, the Amikacin, ARIKACE Specifications, Master Batch Records, ARIKACE SOPs, the Manufacturing of ARIKACE and/or the Commercial Manufacturing Date, then this Agreement and the applicable Schedule shall be amended Contractor Change Proposal in accordance with Section 11.8. Following the procedure described below. 7.1.2. Either party shall present issuance of a written notice to Change Notice under the other party outlining in sufficient detail provisions of Clauses .1, .2 or .3 of this Subsection 11.6, if the proposed changes to Contractor agrees with the relevant Schedule (the “Change Notice”). 7.1.3. Within [***] Business Days after submission , the Contractor shall sign a copy of the Change Notice, Therapure indicating “agreed” next to its signature, and return it to OWNER’s Representative within five (5) Work Days after receipt. A Change Order will then be issued pursuant to this Section 11.1, and the Contractor shall present proceed with the Work indicated in writing to Insmed a quote for work to be undertaken and/or proposed revisions to the Batch Processing Fee (the “Change Fee”), required as a result of the Change Notice, such Change Fee to reflect solely Order. If the incremental costs and Therapure’s reasonable profits associated Contractor disagrees with the Change Notice, as supported by reasonable documentation provided by Therapure to Insmed. 7.1.4. The parties the Contractor shall have [***] Business Days (the “Review Period”) after presentation of sign the Change Fee Notice, indicating “protested” next to discuss its signature, return it to OWNER’s Representative within five (5) Work Days, and follow the protest procedure set forth in Section 11.5. Following receipt of a Change Notice under the provisions Clause .4 of this Subsection 11.6, the Contractor shall sign the Change Fee. On or before the expiry of the Review PeriodNotice, the parties shall: acknowledging its receipt, and return it to OWNER’s Representative within fifteen (i15) accept the Work Days, together with a Contractor Change Fee by executing the Change Fee and related Change Notice (Proposal prepared in accordance with Section 7.1.6) and returning 11.8. The Contractor shall not perform any Work which is the subject of a copy to each other; (ii) discuss proposed amendments to the Change Fee and/or related Change Notice; or (iii) reject the Change Fee in writing (in which case the Change Fee and related Change Notice shall not be effective). 7.1.5. Any amended unless and until a Change Fee and/or related Change Notice mutually agreed and Order is executed by implementing the parties shall be incorporated as part of the relevant Schedule and such Schedule shall be deemed to have been amended to include the Change Fee and/or related Change Notice, as amended. 7.1.6. All or a Change Fees and related Change Notices will be executed (i) on behalf of Therapure by its Vice President, Operations and (ii) on behalf of Insmed by its Vice-President, Technical Operations before they will be deemed Directive is issued pursuant to be effective. In addition, Change Fees and related Change Notices that include changes in the Batch Processing Fees will also be executed (i) on behalf of Therapure by its Chief Executive Officer; and (ii) on behalf of Insmed by its Vice-President, Technical Operations before they will be deemed to be effective. 7.1.7Section 11.7. The parties acknowledge and agree that changes in Schedule A, Schedule BContracting Officer may withdraw a Change Notice without incurring any liability to the Contractor at any time prior to the execution of a Change Order implementing such Change Notice, or Schedule F may result in changes to the pricing set out in this Agreement. If any issuance of a Change Notice may result in documented changes to the pricing set out in this Agreement, the parties shall negotiate an appropriate amendment to this Agreement to reflect Directive implementing such changes, applied retroactively to the effective date of such changesChange Notice.