Termination Due to Regulatory Action. ZymoGenetics may terminate this Agreement upon [ * ] written notice in the event that any Regulatory Authority takes any action, or raises any objection, that has (or could reasonably be expected to have) a material adverse effect on ZymoGenetics’ right or ability to import, export, have manufactured, purchase or sell any Product. In the event ZymoGenetics terminates this Agreement pursuant to this Section 12.5 but within [ * ] thereafter determines that it is able to proceed toward or with the commercialization of Bulk Drug Substance, unless such termination is due to regulatory actions directly affecting Xxxxxx’x ability to operate its biologics manufacturing business or the manufacturing facilities at which the Bulk Drug Substance is being made, Abbott shall have the first right to manufacture the Bulk Drug Substance (exercisable within a [ * ] from the date Abbott receives written notice from ZymoGenetics of such decision to proceed) for such Bulk Drug Substance at the price and upon the terms and conditions set forth in this Agreement.
Termination Due to Regulatory Action. Seattle Genetics may terminate this Agreement upon [*] written notice in the event that a Regulatory Authority takes any action, lasting more than [*], directly affecting Xxxxxx’x ability to operate its biologics manufacturing business or the manufacturing facilities at which the Bulk Drug Substance is being made. Abbott shall take reasonable steps to achieve the orderly transition of the manufacturing process to a Third Party and shall pay all costs payable to said Third Party (other than Affiliates of either Party) (less any costs recoverable by Seattle Genetics in the form of Bulk Drug Substance that may be incorporated into marketable Product) to complete a BLA with respect to the replacement manufacturer’s production of the Bulk Drug Substance provided that Xxxxxx’x share of such costs shall not exceed [*]. Seattle Genetics shall ensure that the Third Party manufacturer shall be subject to terms of confidentiality with respect to Xxxxxx’x Confidential Information, as well as this Section 12.6, that are no less protective than the confidentiality set forth in Article 11 of this Agreement.
Termination Due to Regulatory Action. RFS may terminate this Agreement or any Service Tower upon reasonable notice and without penalty, if a Regulatory Agency formally directs RFS in writing to terminate the Agreement or such Service Tower, provided that RFS has attempted in good faith to allow First Data to participate in the discussions with the regulator, and then fails to modify the applicable services to satisfy the regulator’s requirements within the timeframe requested by or agreed by the regulator (it being understood that RFS may only terminate the Service Tower with respect to the specific Services that the regulator formally directs RFS in writing to terminate and such other portions of the Services that in RFS’ reasonable judgment are directly related thereto).
Termination Due to Regulatory Action. In the event that FERC, or any person, takes any action to subject AECI or AECI’s activities under this Agreement to FERC’s jurisdiction under the Federal Power Act, any Party may terminate this Agreement upon thirty (30) days’ Notice. This provision is not applicable to the exercise of either Party in submitting to FERC a dispute involving this Agreement as provided for in Section 10.1.3, Step Three of the Dispute Resolution Procedures provided in this Agreement.
Termination Due to Regulatory Action. In the event that FERC, or any person, takes any action to subject TVA or TVA’s activities under this Agreement to FERC’s jurisdiction under the Federal Power Act, any Party may terminate this Agreement upon thirty (30) days’ Notice.
Termination Due to Regulatory Action. PGx may terminate this CSA immediately upon written notice to SPT if the FDA or other Regulatory Authority takes any action, the result of which is to prohibit or permanently or otherwise restrict the manufacture, storage, importation, sale, offer for sale or use of Product in any way that will have a material adverse effect on the sale price or sales volume of Product or cause PGx to discontinue sales of Finished Product.
Termination Due to Regulatory Action. Seattle Genetics may terminate this Agreement upon thirty (30) days’ written notice in the event that a Regulatory Authority takes any action, lasting more than six (6) months, directly affecting Xxxxxx’x ability to operate its biologics manufacturing business or the manufacturing facilities at which the Bulk Drug Substance is being made. Abbott shall take reasonable steps to achieve the orderly transition of the manufacturing process to a Third Party and shall pay all costs payable to said Third Party (other than Affiliates of either Party) (less any costs recoverable by Seattle Genetics in the form of Bulk Drug Substance that may be incorporated into marketable Product) to complete a BLA with respect to the replacement manufacturer’s production of the Bulk Drug Substance provided that Xxxxxx’x share of such costs shall not exceed Three Million Seven Hundred Fifty Thousand Dollars (U.S. $3,750,000). Seattle Genetics shall ensure that the Third Party manufacturer shall be subject to terms of confidentiality with respect to Xxxxxx’x Confidential Information, as well as this Section 12.6, that are no less protective than the confidentiality set forth in Article 11 of this Agreement.
