Alternate Supplier. Second, at Company’s written request, if the Third Party Manufacturer is unable to validate and qualify an alternate facility pursuant to clause (i) above, CyDex shall use commercially reasonable efforts to qualify one or more alternate suppliers for the manufacture of Captisol, including without limitation, obtaining Third-Party Manufacturer’s reasonable cooperation with CyDex to qualify such alternate supplier.
Alternate Supplier. Tekmira shall, upon Alnylam’s written request provided to Tekmira at any time after (i) the Effective Date, identify and reasonably verify the suitability of a Third Party as a “backup” supplier of Alnylam Royalty Products as soon as reasonably possible and/or (ii) [**], establish and qualify a Third Party as a “backup” supplier of Alnylam Royalty Products as soon a reasonably possible, but in no event more than twelve (12) months after receipt of such request; provided, however, that the JRC may agree to extend such time periods. Alnylam shall have the right to propose such “backup” supplier(s) and Tekmira shall have the right to consent to such “backup” supplier(s), which consent shall not be unreasonably withheld or delayed. Within thirty (30) days after the Effective Date Tekmira will deliver to the JRC, for review and approval, an update to the Manufacturing Plan containing a project overview for establishing and qualifying a “backup” supplier. This project overview will include contract manufacturing organization targets, timelines, equipment requirements, and both FTE and out-of-pocket expense estimates. The qualification of a “backup” supplier is not intended in any way to alter Tekmira’s rights to Manufacture Alnylam Royalty Products under this Agreement. All internal FTE costs and extraordinary out-of-pocket expenses actually incurred by Tekmira in, and reasonably required, to qualify a “backup” supplier as set forth in this Section 5.1(b) shall be reimbursed by Alnylam (in the case of FTE costs, at the applicable FTE Rate and not to exceed the project overview estimate without the prior approval of the JRC). Tekmira acknowledges and agrees that the FTE Rate reflects Tekmira’s fully-loaded costs and expenses in performing its obligations under the project overview portion of the Manufacturing Plan, and that Tekmira is solely responsible for its costs and expenses in performing its obligations thereunder. However, Alnylam agrees to reimburse Tekmira for any extraordinary out-of pocket costs and expenses incurred by Tekmira in performing its obligations under this Section 5.1(b) to the extent that such out-of pocket costs and expenses are approved by the JRC in advance in writing and are reasonable, documented costs and expenses actually and directly incurred by Tekmira.
Alternate Supplier. In order that SCIOS NOVA is not dependent on a single supplier of BULK SOLUTION and recognizing that regulatory requirements dictate that all BULK SOLUTION utilized by SCIOS NOVA should be manufactured by the same process, BC agrees that beginning in 1998 and pursuant to Article 8.2, SCIOS NOVA may itself use, or have another supplier use, the 150 liter PROCESS or the 3,000 liter PROCESS to produce annually the quantity of BULK SOLUTION that is necessary to yield [*****] of BNP. In addition to the foregoing, in the event BC fails for any reason, including without limitation, a force majeure event described in Article 14.6, to deliver BULK SOLUTION to SCIOS NOVA for a continuous period of 120 days, then SCIOS NOVA shall have the right to make or have made all of its requirements of BULK SOLUTION for the duration of BC’s inability to supply.
Alternate Supplier. If at any time during the Term of this Restated Agreement, including but not limited to periods during the occurrence of an event of force majeure but excepting periods of raw material shortages, ROCHESTER is unable to supply in a timely manner to CONVATEC expected requirements of Products hereunder, then, subject to the limitations set forth in Section 20 hereof, ROCHESTER shall have the right to select and the obligation to utilize an alternate supplier to fill such shortfall until such time as ROCHESTER is able to resume full performance of its supply obligations. With regard to the portion of Product manufactured by an alternate supplier, payment to said supplier for the costs of manufacture shall be the responsibility of ROCHESTER. CONVATEC shall have the right to validate the manufacturing of Product by any alternate supplier hereunder and the right of audit of said alternate supplier upon the same terms and conditions as shall apply to ROCHESTER pursuant to this Restated Agreement.
Alternate Supplier. If APC terminates this Agreement under Paragraph 7.2(c) by reason of FMLP's Default, or FMLP otherwise terminates this Agreement in breach of the terms herein, FMLP shall provide reasonable assistance at APC's expense that APC reasonably requests to establish an alternate supplier of MG-PFH. This assistance shall include describing and explaining FMLP's process for manufacturing MG-PFH in such detail (including the disclosure of FMLP proprietary technology, if necessary) as the alternate supplier may require to manufacture MG-PFH in conformity to the Specification.
Alternate Supplier. MERCK may, upon [*] written notice to SURMODICS, terminate its obligation to exclusively purchase all Product(s) from SURMODICS any time following the Effective Date. [*] “Alternate Supplier” means a source of supply that has the capability to supply Product [*] (the “Alternate Supplier”).
Alternate Supplier. In the event of a SUPPLY INTERRUPTION, CYDEX shall have the right to designate and qualify one or more alternate suppliers for CAPTISOL, which selection need not be approved by HOVIONE (each an “ALTERNATE SUPPLIER”). HOVIONE, at CYDEX’s expense, shall promptly provide at such times and locations as may reasonably be requested by CYDEX, reasonable cooperation to CYDEX in qualifying any ALTERNATE SUPPLIER. From the time that any SUPPLY INTERRUPTION begins until such SUPPLY INTERRUPTION is fully cured, and for a commercially reasonable period of time thereafter, CYDEX may obtain quantities of CAPTISOL from one or more ALTERNATE SUPPLIERS. [***].
Alternate Supplier. If Delivery is suspended or reduced by Seller pursuant to an event or act of Force Majeure, it shall not be a breach of this Agreement for the Companies to buy the Product from a supplier other than Seller for the quantities of the Product which Seller does not Deliver; and the Companies shall not be obligated to buy, after the period of suspension or reduction, the undelivered quantity of the Product which normally would have been sold and Delivered hereunder during the period of suspension or reduction.
Alternate Supplier. In order that CONNETICS is not dependent on a single supplier of PRODUCT and recognizing that regulatory requirements dictate that all PRODUCT utilized by CONNETICS should be manufactured by the same process, BENDXX xxxees pursuant to SECTION 11.2 that CONNETICS may itself use, or have another supplier use, the processes including any BENDXX XXXROVEMENTS, to produce annually two (2) 500 gram lots of PRODUCT. In addition to the foregoing, in the event BENDXX fails for any reason, including without limitation, a force majeure event described in SECTION 14.5, to deliver COMMERCIAL PRODUCT in the full amounts set forth in CONNETICS' purchase orders for a continuous period of 120 days, then CONNETICS shall have the right to make or have made all of its requirements of COMMERCIAL PRODUCT for the duration of BENDXX'x xxxbility to supply.
Alternate Supplier. At Prism’s written request, CyDex shall [***] with [***] the [***] the [***] be [***] to [***] for the [***], the of [***] with [***] to [***].
