Registration of Products. OMP shall be fully responsible for undertaking the compilation and submission of all necessary data information, documents and INDs, CTAs and XXXx relating to the Collaboration Compound and/or Collaboration Product obtained by OMP from ADDEX and/or through the conduct of the Development Work in a format acceptable to the applicable health authorities of the Territory, including but not limited to the FDA and the EMEA, required to obtain Regulatory Approval for the Collaboration Compound and/or Collaboration Product. OMP shall solely own all INDs, CTAs, XXXx, and Regulatory Approvals in the Territory. In the event that ADDEX is developing a Collaboration Compound pursuant to Article 3.6 ADDEX shall undertake this obligations, with respect to such Collaboration Compound, while ADDEX, its Affiliates or Sublicensee is developing such Collaboration Compound.
Registration of Products. ACER will have in its name, at its exclusive costs and according to the regulations in force, country by country, the files for obtaining Approval of the Product. The AP-HP will not be the holder of the Product Approvals.
Registration of Products. NuPathe shall be responsible for preparing in a timely manner the applicable regulatory documents and filing for registration and approval of Products in the Territory. Any sections of the filing for registration relevant for LTS shall be subject to LTS’ prior approval which shall not be unreasonably withheld.
Registration of Products. 6.1 UNI shall be responsible for registering the Licensed Product(s) as may be required by the various countries identified in Section 1.13 hereinabove in which a Licensed Product may be sold by UNI. This registration process, with all accompanying expenses, including additional clinical trials and data as may be required, will be paid solely by UNI.
Registration of Products. 4.1 It being understood that Registration is a prerequisite to the lawful sale of the Products in the Territory, Carrington hereby agrees to supply EAMI, promptly afxxx xxx execution of this Agreement, with any Know-how or relevant documentation necessary for preparing the Registration dossier to be submitted to the applicable governmental authorities of the Territory.
Registration of Products. MEPL must, at its own cost and expense:
Registration of Products. All products on exhibit or for sale in any exhibitor’s booth must be listed in the SIA Show Directory or registered with the SIA Show Management prior to the opening of the SIA Show. Unregistered products will be considered booth sharing and subject to fines.
Registration of Products. Except for the Mutual Recognition Procedure which is in process as of the Effective Date for the Zimycan Product in the European Region, XXXXXX, based on the information provided by BARRIER, will use Commercially Reasonable Efforts to obtain the necessary permits, licenses, authorizations, registrations or approvals that may be required in accordance with each Region's regulations, or under any other Governmental Body, as may be required for the sale, distribution and promotion of the Products in the Territory, unless BARRIER notifies XXXXXX that BARRIER desires to take any such action. To this end, BARRIER shall provide all reasonable assistance as XXXXXX shall request. With respect to such Mutual Recognition Procedure and any other such regulatory action with respect to Products in the Territory that BARRIER undertakes, XXXXXX shall provide all reasonable assistance as BARRIER shall request. ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
Registration of Products. 4.1 It being understood that Registration is a prerequisite to the lawful sale of the Products in the Territory, Xxxxxxxxxx hereby agrees to supply GBV, promptly after the execution of this Agreement, with any Know-how or relevant documentation necessary for preparing the Registration dossier to be submitted to the applicable governmental authorities of the Territory.
Registration of Products. 4.10 The DiaB[TM] and RadiaCare[TM] Products are authorized to be marketed in the U.S., European Union and Pacific Rim by the relevant regulatory body. Carrington authorizes CSC to market the Producxx xxxxx the DiaB[TM] or RadiaCare[TM] names or a name that CSC selects for the Products in the territory covered by this Agreement. This Amendment shall become effective upon its execution by both parties. All other terms and conditions of the Agreement remain unchanged. AGREED AND ACCEPTED BY: CARRINGTON LABORATORIES, INC. _________________________________ Xxxe: Carlton E. Turner, Ph.D., D.Sc. Title: President & CEO XXXXXXXXXX XXXXRATORIES XXXXIUM N.V. _________________________________ Name: Carlton E. Turner, Ph.D., D.Sc. Title: President & CEO XXX XXXXXXXXXXXCALS, LTD XXXLIN _________________________________ Name: Dr. Yervant Zarmanian Title: CEO
