Transfer to Ultragenyx. (i) As soon as practicable after the Effective Date, but in any event no later than sixty (60) days after the Effective Date, Takeda shall timely transfer to Ultragenyx copies of
Transfer to Ultragenyx Sample Clauses
Related to Transfer to Ultragenyx
Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.
Sublicensees Licensee shall have the full right (but not the obligation) to sublicense those rights granted to it under Section 2.1 to a Third Party (a “Sublicensee”); provided, however, that, prior to the payment of the first milestone pursuant to Section 7.2, Licensee may not grant any such sublicense to any contract research organization conducting Clinical Trials of Products or any Third Parties conducting contract Manufacturing activities without Licensee’s prior written notice (at least twenty (20) Business Days in advance) to Lilly, which shall include a description of the rights to be granted and the purpose therefor, the identity of the Third Party and the countries involved, and Lilly’s prior written consent, but such consent shall only be required (i) until such time as Licensee is the holder of record for the Regulatory Materials related to Taladegib and (ii) to the extent such organization is not performing services for Licensee as of the Effective Date; and provided further, that Licensee shall remain responsible for the performance by any of its Sublicensees. With respect to any Sublicensee granted a sublicense to any Commercialization rights hereunder, Licensee shall ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder. Each Sublicensee shall also be prohibited from further sublicensing. For the avoidance of doubt, (a) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (b) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.3.1 and 2.5, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee.
Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.
Third Party Data Any statistical, industry-related and market-related data, which are included in the Disclosure Package and the Prospectus, is based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agrees with the sources from which it is derived, and the Company has obtained the written consent for the use of such data from such sources to the extent required.
Royalty Stacking If COMPANY or an AFFILIATE or SUBLICENSEE is legally required to pay royalties to one or more third parties, in order to obtain a license or similar right necessary to practice the PATENT RIGHTS, and COMPANY, AFFILIATE or SUBLICENSEE actually pays said third party royalties, COMPANY may offset a total of **** of such third-party payments against any royalty payments that are due to THE PARTIES in the same REPORTING PERIOD; provided, however, that in no event shall the royalty payments under this section, when aggregated with any other offsets and credits allowed under the AGREEMENT, be reduced below **** of the running royalty for such a LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT in any REPORTING PERIOD; provided, further, that COMPANY also make best efforts to require such third parties to offset its royalties as a result of royalties payable to THE PARTIES for the Patent RIGHTS by at least the same amount as THE PARTIES has offset its royalties under this Section. For purposes of clarity, third parties may include THE PARTIES.
Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.
Regulatory Filings Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.
Sublicense to Use the Xxxxxxx Trademarks As exclusive licensee of the rights to use and sublicense the use of the "Xxxxxxx," "Xxxxxxx Xxxxxx Investments, Inc." and "Xxxxxxx, Xxxxxxx & Xxxxx, Inc." trademarks (together, the "Xxxxxxx Marks"), you hereby grant the Trust a nonexclusive right and sublicense to use (i) the "Xxxxxxx" name and xxxx as part of the Trust's name (the "Fund Name"), and (ii) the Xxxxxxx Marks in connection with the Trust's investment products and services, in each case only for so long as this Agreement, any other investment management agreement between you and the Trust, or any extension, renewal or amendment hereof or thereof remains in effect, and only for so long as you are a licensee of the Xxxxxxx Marks, provided however, that you agree to use your best efforts to maintain your license to use and sublicense the Xxxxxxx Marks. The Trust agrees that it shall have no right to sublicense or assign rights to use the Xxxxxxx Marks, shall acquire no interest in the Xxxxxxx Marks other than the rights granted herein, that all of the Trust's uses of the Xxxxxxx Marks shall inure to the benefit of Xxxxxxx Trust Company as owner and licensor of the Xxxxxxx Marks (the "Trademark Owner"), and that the Trust shall not challenge the validity of the Xxxxxxx Marks or the Trademark Owner's ownership thereof. The Trust further agrees that all services and products it offers in connection with the Xxxxxxx Marks shall meet commercially reasonable standards of quality, as may be determined by you or the Trademark Owner from time to time, provided that you acknowledge that the services and products the Trust rendered during the one-year period preceding the date of this Agreement are acceptable. At your reasonable request, the Trust shall cooperate with you and the Trademark Owner and shall execute and deliver any and all documents necessary to maintain and protect (including but not limited to in connection with any trademark infringement action) the Xxxxxxx Marks and/or enter the Trust as a registered user thereof. At such time as this Agreement or any other investment management agreement shall no longer be in effect between you (or your successor) and the Trust, or you no longer are a licensee of the Xxxxxxx Marks, the Trust shall (to the extent that, and as soon as, it lawfully can) cease to use the Fund Name or any other name indicating that it is advised by, managed by or otherwise connected with you (or any organization which shall have succeeded to your business as investment manager) or the Trademark Owner. In no event shall the Trust use the Xxxxxxx Marks or any other name or xxxx confusingly similar thereto (including, but not limited to, any name or xxxx that includes the name "Xxxxxxx") if this Agreement or any other investment advisory agreement between you (or your successor) and the Fund is terminated.
Subdistributors Subject to the provisions of this Section 2.2, Nipro --------------- may appoint one or more third parties, with a reputation for competence and ethical behavior, within any portion of the Territory to distribute the FreeStyle Products in the Field of Use. Within twenty (20) days after the appointment of such Subdistributor, Nipro shall notify TheraSense of the identity of such Subdistributor. Nipro shall not sell or otherwise transfer the FreeStyle Products to any Subdistributor until such Subdistributor enters into a form of written agreement ("Subdistributor Agreement") with Nipro, binding the Subdistributor to terms and conditions substantially similar to those terms and conditions agreed upon by Nipro in this Agreement. Further, Nipro shall only grant Subdistributors the right to make sales of the FreeStyle Products in the Territory in the Field of Use. Nipro agrees to terminate a Subdistributor's right to distribute the FreeStyle Products promptly upon becoming aware that such Subdistributor, or its authorized distributor(s) or reseller(s), is selling or otherwise distributing the FreeStyle Products in violation of its Subdistributor Agreement. Each Subdistributor Agreement shall contain provisions making TheraSense a direct and intended third party beneficiary of such Subdistributor Agreement.
