Terms and Conditions of EMPROVE® Dossier Access



Applicable for all Dossiers provided by Merck KGaA, Frankfurter Str. 250, 64923 Darmstadt Germany, acting through its division EMD Millipore Corporation, 400 Summit Drive, Burlington, MA, USA 01803 ("SELLER") to the purchasing company ("COMPANY")

  1. SELLER only provides the respective EMPROVE® Dossiers or EMPROVE® Suite access according to this terms and conditions and solely for regulatory use. The Dossiers are not appropriate for regulatory submission as active pharmaceutical ingredient.

  2. COMPANY is entitled to share the ordered Dossiers with any of its affiliates which means, for such purpose, any corporation or other business entity controlling, controlled by or under common control of the COMPANY by the direct or indirect ownership of more than fifty percent (50%) of the voting interest in the COMPANY or such corporation or other entity (“Affiliates”).  Sharing the Dossiers with and assignments to other parties (not including authorities during regulatory procedures) are prohibited.

    If COMPANY is planning to share information with any of its Affiliates, it has to first bind the Affiliate to the same conditions the COMPANY accepts herewith.

  3. COMPANY has to retain in confidence all information contained in the EMPROVE® Dossiers disclosed to it by or on behalf of SELLER for ten (10) years after receipt.  This restriction may be waived only upon written consent given by SELLER, which consent will not be withheld in case of good reason.

  4. COMPANY has to limit disclosure of the EMPROVE® Dossiers provided by SELLER to only those of its officers, representatives and employees (collectively "Representatives") who are directly concerned with regulatory matters. COMPANY has to (i) advise its Representatives of the proprietary nature and the conditions accepted hereunder and (ii) use all reasonable safeguards to prevent unauthorized disclosure by such Representatives and (iii) shall not use the information contained in the EMPROVE® DOSSIER or provided therewith to purchase similar information at third parties. COMPANY is responsible for any breach of this Agreement by its or its affiliated company’s Representatives. The Affiliates of COMPANY or SELLER shall not be regarded as third parties for this purpose, provided they are bound to confidentiality, proven by COMPANY.

  5. SELLER is not obligated to disclose any further information to COMPANY or to provide any license or other right to the COMPANY. The COMPANY may not assign any right hereunder without the prior written consent of SELLER.

  6. The COMPANY understands, that SELLER will use its best commercially reasonable efforts regarding the accuracy, completeness or reasonableness of the information contained in the EMPROVE® DOSSIER, but SELLER does not take over any representation or warranty, express or implied, as to the accuracy, completeness or reasonableness of the EMPROVE® DOSSIER, and that neither SELLER nor any of its employees, officers or consultants shall have any liability to the COMPANY as a result of the COMPANY's possession or use of the EMPROVE® DOSSIER. The limitation of liability shall not apply in case any damage is caused by SELLER with gross negligence or willful misconduct.

  7. The COMPANY´s order, any agreement based on it and any dispute arising out of it shall exclusively be without regard to conflict of law principles subject to the laws of Germany. It is understood and agreed that both parties hereby exclusively submit to the jurisdiction of the competent courts in Frankfurt am Main, Germany.

  8. Any order shall only become binding on SELLER after the COMPANY accepts the provisions hereunder and SELLER decides to deliver the respective EMPROVE® DOSSIER to the COMPANY and without giving any further statements or commitments to the COMPANY.

  9. SELLER will make the ordered EMPROVE® DOSSIER available for the individual COMPANY as a pdf-file in its own discretion. The file will be made available on SELLER’s website. This will usually take approximately ten (10) working days after receipt of the order. SELLER preserves the right to inform the Customer about further delays. The price will be invoiced by SELLER and is due for payment by the COMPANY within thirty (30) days from the date of the invoice.

  10. The order form, signed by the customer, may be delivered by facsimile or electronic (pdf) transmission, and facsimile or electronic (pdf) copies of executed documents shall be binding as originals.