Cell Washing System definition

Cell Washing System shall refer to Equipment and Disposables and does not include leukoreduction, delivery and incubation of the Viral Inactivation Agent.
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Examples of Cell Washing System in a sentence

  • The specifications, development guidelines, pricing, and milestones herein are applicable to a Cell Washing System and Viral Inactivation System to be marketed and sold in the United States.

  • VITEX shall have no obligation to make royalty payments (i) if Haemonetics' 510(k) for a Cell Washing System is not approved by FDA within two (2) years of submission, except if the delay or failure to obtain approval is caused by VITEX, or (ii) if VITEX can demonstrate that Haemonetics could not make available a Cell Washing System that would be approvable by FDA.

  • Haemonetics shall have no obligation for worldwide inventory, marketing, and sale of the Viral Inactivation System, including the Cell Washing System to be used with it, though Haemonetics' name shall appear on all Equipment and Disposables as the manufacturer of those products.

  • If the parties disagree as to the best method for achieving a specification or a process, then Haemonetics shall make the final decision if the disagreement relates to the Cell Washing System and VITEX shall make the final decision if the disagreement relates to the Viral Inactivation Agent.

  • Haemonetics shall be responsible for managing regulatory approval of the Cell Washing System within and outside ---------------- Confidential materials omitted and filed separately with the Securities and Exchange Commission.

  • Except as set forth above, Haemonetics shall defend, indemnify and hold VITEX, its directors, officers, employees, and agents harmless from any cost, expense, or liability (including attorneys' fees) or claims of third parties, including any human subjects, arising out of a defect of the Cell Washing System, except to the extent caused by the negligence, gross negligence or willful misconduct of VITEX, the Naval Blood Research Laboratory when acting for VITEX, or others acting on behalf of VITEX.

  • For the term of this Agreement, and subject to the terms and conditions herein, VITEX and Haemonetics shall collaborate to develop a Cell Washing System that can be utilized with the Viral Inactivation Agent to inactivate pathogens in red cells and then to remove or neutralize the inactivation agent.

  • VITEX will provide Haemonetics with clinical data as needed to support complementary 510(k)'s for the Cell Washing System or other 510(k)'s outside of the area of viral inactivation.

  • Labor costs associated with manufacture of the Cell Washing System during the development phase shall be based on anticipated wage rates, fringe benefits costs, and standard labor minutes per product.

  • Each party shall provide the other party with those sections of regulatory submissions that relate specifically to the other party's Cell Washing System or Viral Inactivation Agent in order to ensure the truth and accuracy of such information and to support the other party's regulatory filings.

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