CHANGE IN MANUFACTURER Sample Clauses

CHANGE IN MANUFACTURER. As of the EFFECTIVE DATE, SYNAGIS is manufactured by Boehringer Ingelheim in Germany [***]. Subject to the conditions of this Section 7.8, MEDIMMUNE may delegate the manufacture of any PRODUCT to an alternate THIRD PARTY MANUFACTURER or an AFFILIATE of MEDIMMUNE. MEDIMMUNE shall provide XXXXXX with prior written notice of any proposed change in the THIRD PARTY MANUFACTURER of any PRODUCT hereunder at least eighteen (18) months prior to such change and shall seek the written consent of XXXXXX, which consent shall not be unreasonably withheld; provided, however, in the event that it is not commercially reasonable for MEDIMMUNE to provide eighteen (18) months notice under the circumstances, the PARTIES shall work cooperatively to establish a mutually acceptable timeline for effecting such change. Notwithstanding the foregoing, in the event that MEDIMMUNE is [***], the PARTIES acknowledge and agree that MEDIMMUNE may engage another THIRD PARTY MANUFACTURER for NUMAX (or manufacture NUMAX itself or through an AFFILIATE) with written notice to XXXXXX as soon as reasonably practicable. XXXXXX shall be deemed to have reasonably withheld consent to a proposed change in the manufacturer of any PRODUCT if such change will result in a material disruption of the supply of the PRODUCT or have a material adverse impact on pending or existing REGULATORY FILINGS or REGULATORY APPROVALS of the PRODUCTS, provided however that, XXXXXX may withhold such consent for no longer than such reasonable period as required to notify and obtain any consents to such change in manufacturer as may be required by REGULATORY AUTHORITIES in the TERRITORY. In the event that a change in manufacturer would result in a material financial impact to XXXXXX unanticipated in the ordinary course of business, MEDIMMUNE agrees to negotiate in good faith with XXXXXX a reasonable allocation between the PARTIES for the incremental costs resulting from such change in manufacturer including, but not limited to, significant additional freight costs (to the extent materially different), but excluding, without limitation, any expenses incurred by XXXXXX to amend REGULATORY FILINGS made by XXXXXX in the TERRITORY related to such change. MEDIMMUNE shall remain primarily liable to XXXXXX in connection with the quality and supply of the PRODUCTS supplied hereunder and nothing in this Section 7.9 shall be construed to reduce or limit the obligations of MEDIMMUNE or the rights of XXXXXX pursuant to the remaining term...
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Related to CHANGE IN MANUFACTURER

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