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.
4.2 It shall be the responsibility of EAMI, at its sole expense to apply for, obtain and maintain in force the Registration of the Products. Subject to having obtained the prior approval of Carrington, the application shall be submitted to all apxxxxxxxx governmental authorities, including the health authorities of the Territory and said application shall be in the name of Carrington, with EAMI being named as Products agent xxx xxxxxibutor in the Territory. EAMI expressly acknowledges and agrees that the absolute a n d exclusive ownership of the Registration and all rights originating out of or from the same shall at all times belong only and exclusively to Carrington and EAMI is Carrington's agent, therefore.
4.3 As soon as EXXX xxx xxxxived Know-how from Carrington, EAMI shall prepare, at its sole expense, xxx Xxxxxxration dossier and submission and any translation which may be required by the applicable authorities of the Territory. EAMI shall promptly supply Carrington with a copy of the said Registration dossxxx xxx submission and Carrington shall be entitled to a free and unrestrxxxxx xxx of the same.
4.4 Subject to having obtained Carrington's written approval of all such documentation xxx xxx xxxsequent amendments thereto, EAMI shall, as soon as possible and in any case within sixty (60) days of Carrington's approval, submit the Registration applicatiox xx xxx appropriate authorities of the Territory.
4.5 EAMI shall use its best endeavors to obtain the Registration within one (1) year from the relevant submission. EAMI shall notify Carrington in writing at least 3 (three) months before the xxxxxxxxon of said term of any need for an extension in time to obtain Registration. The notification shall specify the duration of, and the reason for, any proposed extension. Carrington shall consider any such request, evaluating xxx xxxxxtive situation and EAMI's fulfilment of its obligations in this respect. It is, however, understood that EAMI's deadline to obtain Registration is one year from the date of filing.
4.6 EAMI shall copy and keep Carrington fully and timely informed, throughout the...
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. 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. 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.
6.2 RXPC hereby gives UNI full access and all necessary rights to all available clinical and development studies, product development, unpublished works, products, technology and know-how, patent information, laboratory records, manufacturing know-how and records, laboratory protocols, product protocols, and scientific research relating to the Licensed Products that were prepared by or are owned by RXPC or to which RXPC has rights, for use in filing any and all product registrations, as may be required or appropriate. RXPC will also assist UNI, as requested by UNI and without additional cost, in seeking rights to other related data and tests.
6.3 Any and all required registrations throughout the territory will be solely at the expense of UNI. Notice of any registration filings and receipt of any registrations will be provided to RXPC within 10 days of filing of said registration or receipt of notice of registration by UNI.
6.4 UNI shall file additional product registration applications as it deems necessary to enter relevant markets.
6.5 UNI shall regularly inform RXPC of the status of the activities with regard to the registration and the granting of the registrations.
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. MEPL must, at its own cost and expense:
(a) register and maintain the registration of Products for use in the Field in accordance with any applicable laws, rules and regulations of any Government Agency; and
(b) do everything necessary to apply for and obtain each Authorisation from a Government Agency required by any applicable law in the Territory for the importation, promotion, distribution, storage, sale and use of Products in the Field.
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. 3.1 BLI shall prepare and file any IND necessary to enable BLI and BCI to carry out their obligations under this Agreement for any Product.
Registration of Products. (a) THE DISTRIBUTOR shall at its own cost, ensure and complete the Registration of PRODUCT in the TERRITORY diligently. However BMI agrees to supply to THE DISTRIBUTOR subject to obligation of confidentiality of BMI, all documents, PRODUCT samples, and any other requirements for enabling the DISTRIBUTOR to Register the PRODUCT listed in Annex A with the relevant authorities or distribution partners in the Territory.
(b) THE DISTRIBUTOR has the duty to provide BMI and inform sufficiently in advance with the requirements of information/document details for registration of THE PRODUCT with reference to the respective Authorities of the Territory, in detail.
(c) The documents and PRODUCT samples will be provided directly to THE DISTRIBUTOR who in turn will submit to the relevant authorities or distribution partners under notice to BMI. The registration files, documents, PRODUCT sample which are supplied by BMI will be used by THE DISTRIBUTOR for PRODUCT registration only and the DISTRIBUTOR shall maintain absolute confidentiality of all information disclosed to the relevant authorities and not for any other purpose. The DISTRIBUTOR has no right to divulge any part of the said files to any third party, under any circumstances and the DISTRIBUTOR is aware that BMI would be put to great financial and business loss if this obligation of confidentiality is breached by the DISTRIBUTOR.
Registration of Products. INTEC shall (i) be responsible for preparing the applicable regulatory documents and filings for registration and approval of Product, (ii) use only such documents created by LTS under the Development Activities approved for such filing purpose and (iii) inform LTS of such filing and/or approvals in due time.
