KLH definition
Examples of KLH in a sentence
PerImmune shall Manufacture all KLH Requirements for use in the commercialization of any Ganglioside Vaccine (i) strictly in compliance with (A) this Agreement, (B) all Specifications, and (C) all applicable laws and regulations, including but not limited to cGMPs to the extent applicable, and (ii) in a PerImmune facility holding all applicable licenses in the jurisdiction of Manufacture.
Together with each such lot of KLH Requirements, PerImmune shall provide a written certificate of analysis which shall set forth the results of such testing by PerImmune and PerImmune's quality control approval of such lot of KLH Requirements.
PerImmune shall test each lot of KLH requirements Manufactured for Progenics or as required under the Specifications.
Each Party assumes full responsibility and liability for any injury, damage or expense which it or its employees, agents and invitees incur and which arise from its manufacture, handling and use of KLH or Ganglioside Vaccines, except to the extent such injury, damage or expense arises from the negligence or willful misconduct of the other Party.
PerImmune shall be solely responsible, at its sole cost and expense, for obtaining all necessary regulatory approvals particular to KLH for Manufacture and supply of KLH Requirements.
Upon submission of a proposal by Progenics which is approved by PerImmune, PerImmune shall permit Progenics to audit, in cooperation with PerImmune's personnel, production, packaging, and quality control facilities of PerImmune and any of its significant suppliers as they relate to production of KLH to allow Progenics to verify PerImmune's compliance with its responsibilities under this Agreement.
During the Term, commencing on July 1 , 1996 and on an on-going quarterly basis as described below, Progenics will provide PerImmune with a written rolling annual demand forecast of KLH Requirements for each manufacturing Year which shall be binding as to the first quarter and non-binding as to the remaining three (3) quarters.
PerImmune shall not assert against Progenics or its customers any patents now or hereinafter owned or controlled by PerImmune which concern KLH or any Ganglioside Vaccine of Progenics which incorporates KLH.
In the event that PerImmune is unable to supply [***] of Progenics' purchase orders for two consecutive quarters, then PerImmune agrees to provide Progenics the right and license to use the relevant Know-how to manufacture or have manufactured KLH for use in producing Ganglioside Vaccine, and to fully cooperate with regulatory authorities to qualify Progenics and/or its designee as a manufacturer of KLH.
Progenics shall be entitled to test any such KLH Requirements in accordance with the Specifications, at Progenics' sole expense.