Regulatory Approval of Products. Distributor shall submit all appropriate applications and materials necessary to obtain regulatory approval required for the importation and sale of the Product and Product Servings in the Territory upon NutraCea’s delivery of any necessary documents for product registration and import permit application to Distributor. Distributor shall use its best efforts to obtain necessary approvals during calendar year 2005, after which this Agreement will expire at NutraCea’s option, if necessary or appropriate approvals are not obtained.
Regulatory Approval of Products. Licensee or the Joint Entity shall submit all appropriate applications and materials necessary to obtain regulatory approval required for the sale of the Products in the Territory upon NutraCea’s delivery of all the required technical data and appropriate documents for product registration to Licensee.
Regulatory Approval of Products. Orthovita shall have primary responsibility, at its sole cost, for obtaining all necessary U.S. and foreign Approvals for the Initial Products for use, sales, marketing and distribution, including the performance of animal and clinical trials, if necessary. KNC anticipates performing significant work assisting Orthovita in the preparation and writing of the 510(k) applications and will cooperate with Orthovita to the extent KNC’s participation is reasonably necessary or appropriate in order for Orthovita to procure such Approval, it being understood that KNC shall not be required to perform any animal tests or clinical studies required for Approval, unless otherwise agreed to in the Development Plan or Project Plan or otherwise by the parties. Without limiting the generality of the foregoing, Orthovita shall make all necessary submissions in the U.S. with the United States Food and Drug Administration and any successor agency thereto (“FDA”) under the Orthovita name. Orthovita shall provide to KNC copies of any written communications to or from the FDA or other Governmental Authority, and notify KNC of any oral communications with the FDA or other Governmental Authority, relating to a Master File or other document filed with such Governmental Authority, promptly after any such communications are sent or received, redacted of any proprietary information. In the event FDA or other Governmental Authority requests additional information from Orthovita, Orthovita shall advise KNC of the estimated date by which it will respond to such request, and the date that the response is submitted. KNC will make available to Orthovita, without charge, tangible written information in KNC’s possession and control that is required to prepare a submission for Approval, as Orthovita may reasonably request, as is reasonably necessary to obtain Approval, which information shall be presented in a form which satisfies the requirements of applicable FDA guidelines and/or regulations for such types of submissions seeking Approval. Notwithstanding the foregoing, in the case of sensitive confidential or proprietary manufacturing or other information in a Master File or comparable document, KNC may instead agree to provide such information directly to the FDA or other applicable Governmental Authority, as the case may be, or to an independent third party of its choosing which is reasonably acceptable to Orthovita, and shall respond directly (or through its independent agent) to any ques...
Regulatory Approval of Products. The Parties agree that the following procedure is in conformity with the provisions of paragraph 4 of Article VI of this Agreement: When applying for an application for marketing approval of a generic product, the applicant (the "second" submitter) can prove the equivalence of its own product with the original one, on the basis of a sample of the commercially available original product, while referring to the original documentation if needed. When deciding on the approval of the "second" application, the competent authority bases its decision on the examination of the documentation attached to this application. During the procedure the authority in question does not reveal any information in any form on the documentation of the original product. Washington, September 24, 1993 Dear Mr. Minister: I have the honor to provide the following information regarding performers' rights in the United States. In the United States performers are eligible to be joint authors of a sound recording under the copyright law, and thus foreign performers are entitled to national treatment under Article 5 of the Berne Convention. In addition, state courts and legislators have taken strong steps to protect performers against the unauthorized fixation of their performances without regard to international obligations of the United States --thus extending the protection of United States law to performers of all nationalities regardless of where the performance took place, provided that some restricted act occurred within the jurisdiction of a relevant court. Two underlying principles of the protection of performers' rights in the United States deserve mention. The first is that the ability of a performer to prevent unauthorized fixations and reproductions of his or her live performance is deemed to be so fundamental that legislators and courts alike are willing and prepared to find creative solutions to ensure basic fairness and justice. The second, in many respects related to the first, is that because such protection is so fundamental, it is not tied to reciprocity or obligations under existing international conventions. The nationality of the performer and the location of the performance have no relevance to any determination under United States law. Under the statutes referenced herein, the analysis is simple. If a person fixes the sounds of a live performance, or reproduces, distributes, or sells such a fixation, he or she commits an offense that in many states is punishable b...
