Material Project Documents (a) The Company shall at all times (i) perform and observe all of the covenants under the Material Project Documents to which it is a party and take reasonable actions to enforce all of its rights thereunder, other than to the extent the same could not reasonably be expected to have a Material Adverse Effect, (ii) subject to the provisions of clause (b) of this Section 9.8, maintain the System Leases (other than Leases constituting System Leases only pursuant to clause (5) of the definition thereof) in full force and effect, and (iii) maintain the Leases (other than the System Leases referred to in the foregoing clause (ii) of this Section 9.8(a)) to which it or any of its Subsidiaries is a party in full force and effect, except to the extent the same could not reasonably be expected to have a Material Adverse Effect. (b) If the term of a Lease with the Company or one of its Subsidiaries expires and the Qualified Lessee under such Lease has either ceased operating the related assets or has ceased paying rent as required under the applicable Lease, the Company shall, or shall cause a Subsidiary, as applicable, to enter into a supplement or a new Lease with respect to the related leasehold assets with a Qualified Lessee that provides for rent that, when combined with all other expected revenue, will, in the reasonable judgment of the Company, as of the commencement date of such supplement or new Lease, generate sufficient revenue to satisfy the requirements of Section 9.9 and will not otherwise result in a materially worse position for the Company as compared to the terms of the applicable expired Lease. Each such new Lease shall have a term of at least five years. Notwithstanding the foregoing, if (i) such expired Lease relates to transmission and/or distribution assets that are not generating significant revenue, (ii) the failure to renew such Lease would not constitute a Material Adverse Effect and (iii) the Company reasonably believes it will generate sufficient revenue and hold sufficient assets (without giving effect to the leasehold assets with respect to such Lease) to satisfy the requirements of Section 9.9, then this Section 9.8(b) will not require a supplement or new lease with respect to such leasehold assets.
Clinical Supply Servier shall be primarily responsible for manufacturing and supplying bulk Licensed Oligos and finished Licensed Products for use in clinical studies conducted pursuant to the Development Plan in the Field in the Territory, provided that Servier may engage Miragen for such manufacture and supply as follows: At least 180 days prior to the anticipated filing of the first CTA for the first indication with respect to a Licensed Product, Servier shall notify Miragen in writing whether it desires to engage Miragen for such manufacture and supply. If Servier chooses to have Miragen provide such clinical supply, Servier and Miragen shall negotiate in good faith and enter into a separate supply agreement having mutually agreed terms with respect to such clinical supply, which supply shall be at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]). For clarity, Miragen’s manufacturing-related Development costs, as described in Section 1.27(e), [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. are not included in the Cost of Goods but shall be included in Development Plan Costs and shared by the Parties pursuant to Section 9.3. If Servier does not engage Miragen but elects to manufacture and supply bulk Licensed Oligos and finished Licensed Products for Development purposes, either through itself or its Third Party manufacturer, then Miragen shall have the right to purchase such bulk Licensed Oligos and finished Licensed Products from Servier at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]), and the other terms and conditions to be agreed upon by the Parties and set forth in a separate supply agreement. For clarity, Miragen shall have the right to manufacture and have manufactured, anywhere in the world, the Licensed Oligos and Licensed Products for clinical and commercial use outside the Territory.
Commercial Supply i) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the Commercial Supply Agreement, Onconova shall be obligated, by itself or through its Third Party contract manufacturer, to supply to SymBio, and SymBio shall be required to purchase, all quantities of the Commercial Product required by SymBio to commercialize the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement shall be consistent with the terms set forth in this Article 5, and shall include customary and reasonable terms and conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. Without limiting the foregoing, the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “▇▇▇▇ Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no event shall the ▇▇▇▇ Up exceed **, and further provided that in no event shall the sum of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed **. The foregoing calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes of calculating the ▇▇▇▇ Up.
SIGNIFICANT CUSTOMERS; MATERIAL CONTRACTS AND COMMITMENTS The Company has delivered to TCI an accurate list (which is set forth on Schedule 5.15) of all customers (persons or entities) representing 1% or more of the Company's annual revenues for the year ended December 31, 1997; provided, however, that Schedule 5.15 need not set forth more than the Company's 20 largest customers during such period. Except to the extent set forth on Schedule 5.15, none of such customers have canceled or substantially reduced or, to the knowledge of the Stockholders, are currently attempting or threatening to cancel a contract or substantially reduce utilization of the services provided by the Company. The Company has listed on Schedule 5.15 all Material Contracts (as defined below) to which the Company is a party or by which it or any of its properties are bound, other than agreements listed on Schedules 5.10, 5.14 or 5.16, (a) in existence as of the Balance Sheet Date and (b) entered into since the Balance Sheet Date, and in each case has delivered true, complete and correct copies of such agreements to TCI. For purposes of this Agreement, the term "Material Contracts" includes contracts between the Company and significant customers (as described above), joint venture or partnership agreements, contracts with any labor organization, strategic alliances, options to purchase land and other contracts which are not terminable on sixty days or less notice and involve payments by the Company in any twelve-month period in excess of $25,000. The Company has also indicated on Schedule 5.15 a summary description of all plans or projects involving the opening of new operations, expansion of existing operations, the acquisition of any personal property, business or assets requiring, in any event, the payment of more than $25,000 by the Company during any 12- month period. To the knowledge of the Stockholders, all of the Material Contracts are in full force and effect and constitute valid and binding agreements of the parties (and their successors) thereto in accordance with their respective terms except as the enforceability thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to the enforcement of creditors' rights generally and by general principles of equity.
Material Contracts and Transactions Other than as expressly contemplated by this Agreement, there are no material contracts, agreements, licenses, permits, arrangements, commitments, instruments, understandings or contracts, whether written or oral, express or implied, contingent, fixed or otherwise, to which Pubco is a party except as disclosed in writing to Priveco or as disclosed in the Pubco SEC Documents.