Common use of Facility Construction Clause in Contracts

Facility Construction. In consideration of Nordion establishing the Facility, Molecular Insight Pharmaceuticals will pay to Nordion the fees as set out in Schedule C, provided that the respective milestone(s) for establishing the Facility as set forth on Schedule A attached hereto are materially met by Nordion. Unless otherwise set out (see Schedule C) amounts owing by Molecular Insight Pharmaceuticals during the Facility program shall be paid within thirty (30) days of receipt of Nordion’s invoice. Nordion shall establish the Facility in accordance with its obligations described and attributed in Schedule A, it being understood that some activities may be reasonably delayed to the extent that such activity is premised on the work or provision of data, information, equipment or technology by Molecular Insight Pharmaceuticals, and provided that such activities do not materially interfere or could be reasonably expected to interfere with other established Nordion production activities. Molecular Insight Pharmaceuticals acknowledges that there may be risks and/or unforeseen circumstances that are associated with the implementation of Facility Program that may impact Nordion’s overall achievement of the Milestone Schedule and may result in delays and/or increased Facility costs (from those originally estimated). In that the aggressive timeline for implementation of the project was prepared at the request of Molecular Insight Pharmaceuticals, it is acknowledged by Molecular Insight Pharmaceuticals that such timeline may not, in the ordinary course, be achievable. It is understood and acknowledged that due to the nature of the activities to be carried out during the establishment of the Facility, the time for completion and sequence for carrying out the activities as set out in Schedule A shall therefore serve only as a guide. Subject to the foregoing each party shall use their commercially reasonable efforts in order to carry out their respective obligations and responsibilities set out in Schedule A. The Process established under the Scale-up Agreement being transferred to the Facility and validated under this Agreement has a 15 Ci starting activity of Isotope. It is assumed this Process and related methods have been fully validated and utilized in the current interim facility established under the Interim Facility Agreement. Yields are as described in Schedule D. Molecular Insight Pharmaceuticals accepts that the success of work detailed in this Agreement is dependant upon the successful completion of the 15 Ci process developed under the Scale-up Agreement. Nordion shall, in consultation with Molecular Insight Pharmaceuticals, develop and implement a Master Validation Plan that will allow the production of Azedra under cGMPs for Clinical Trial supply and for Commercial Phase supply. Prior to implementation, both parties shall in writing approve the Master Validation Plan, which approval will not be unreasonably or untimely withheld.

Appears in 2 contracts

Sources: Commercial Facility and Supply Agreement (Molecular Insight Pharmaceuticals, Inc.), Commercial Facility and Supply Agreement (Molecular Insight Pharmaceuticals, Inc.)

Facility Construction. In consideration of Nordion establishing the Facility, Molecular Insight Pharmaceuticals will pay to Nordion the fees as set out in Schedule C, provided that the respective milestone(s) for establishing the Facility as set forth on Schedule A attached hereto are materially successfully met by Nordion. Unless otherwise set out (see Schedule C) amounts owing by Molecular Insight Pharmaceuticals during the Facility program shall be paid within thirty (30) days of receipt of Nordion’s invoice. Nordion shall establish the Facility in accordance with its obligations described and attributed in Schedule A, it being understood that some activities may be reasonably delayed to the extent that such activity is premised on the work or provision of data, information, equipment information or technology by Molecular Insight Pharmaceuticals, and provided that such activities do not materially interfere or could be reasonably expected to interfere with other established Nordion production activities. Molecular Insight Pharmaceuticals acknowledges that there may be risks and/or unforeseen circumstances that are associated with the implementation of Facility Program that may impact Nordion’s overall achievement of the Milestone Schedule and may result in delays and/or increased Facility costs (from those originally estimated). In that the aggressive timeline for implementation of the project was prepared at the request of Molecular Insight Pharmaceuticals, it is acknowledged by Molecular Insight Pharmaceuticals that such timeline may not, in the ordinary course, be achievable. It is understood and acknowledged that due to the nature of the activities to be carried out during the establishment of the Facility, the time for completion and sequence for carrying out the activities as set out in Schedule A shall therefore serve only as a guide. Subject to the foregoing each Each party shall use their commercially reasonable best efforts in order to carry out out, in a timely manner, their respective obligations and responsibilities set out in Schedule A. The Process established under If either party, acting in good faith, materially fails to satisfy any Facility Milestone or is unable to meet such milestone in accordance with the Scale-up Agreement being transferred timing set out in Schedule A, such party shall provide written notice thereof to the Facility other party and validated under this Agreement has the parties shall determine a reasonable corrective action plan and revised milestone schedule. The payment schedule set forth on Schedule C shall be revised appropriately to reflect the revised milestone schedule. If the parties are unable to agree to a reasonable corrective action plan or revised milestone schedules after good faith negotiations for a period of 15 Ci starting activity days, either party may submit such matter to binding arbitration pursuant to the JAMS Streamlined Rules and Procedures (except that each side shall be entitled to take up to two depositions prior to the arbitration hearing), with such arbitration to be held in Boston, MA. The arbitration shall be held before one arbitrator with appropriate experience with respect to such dispute who shall be mutually agreed upon by the parties and if there is no agreement by the parties (within 10 days of Isotope. It is assumed this Process and related methods have been fully validated and utilized in the current interim facility established under the Interim Facility Agreement. Yields are as described in Schedule D. Molecular Insight Pharmaceuticals accepts that the success of work detailed in this Agreement is dependant upon the successful completion submission to arbitration) then such arbitrator shall be selected pursuant to Rule 12 of the 15 Ci process developed under JAMS Streamlined Rules and Procedures. The arbitrator shall have the Scale-up Agreementauthority to modify the contract in a manner consistent with the arbitrator's resolution of such dispute and shall be entitled to use equitable remedies to enforce the arbitration decision. The arbitration decision may also be enforced by any court of competent jurisdiction. The costs (including attorneys fees) of the arbitration and the fees of the arbitrator shall be allocated as the arbitrator deems appropriate. After the Facility is completed, Nordion shall, in consultation with Molecular Insight Pharmaceuticals, develop and implement a Master Validation Plan that will allow the production of Azedra BMIPP under cGMPs for Clinical Trial supply and for Commercial Phase supply. Prior to implementation, both parties shall in writing approve the Master Validation Plan, Plan which approval will not be unreasonably withheld. The parties acknowledge and agree that Schedule A may be amended during the course of establishing the Facility to accommodate unforeseen events and results. All such changes to Schedule A shall be made by written agreement of the parties. If any change to Schedule A materially impacts the scope of work to be provided by Nordion, Nordion will provide a written estimate of the increase cost, which must be approved in advance by Molecular Insight Pharmaceuticals. No work on such scope change shall be carried out by Nordion prior to Nordion's receipt of Molecular Insight Pharmaceuticals' written approval of such change. The parties, upon signing this Agreement, shall each designate a program manager, who shall be responsible for coordinating communication and monitoring performance under this Agreement. The program managers shall meet monthly, in person or untimely withheldby telephone, for the purpose of reviewing the status of the project and assessing progress against the milestones and activities set forth in Schedule A. Minutes of meetings shall be prepared, maintained and provided to each of the parties. Prior to the monthly meetings, Nordion shall prepare and submit to Molecular Insight Pharmaceuticals a written report that sets forth in reasonable detail the progress of the Facility construction and indicates any problems that are known to Nordion or reasonably anticipated by Nordion to occur that either may result in the schedule for the Facility not being met in a timely manner or may result in a cost increase to be borne by Molecular Insight Pharmaceuticals.

Appears in 1 contract

Sources: Supply Agreement (Molecular Insight Pharmaceuticals, Inc.)