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Section 314 (or any successor application thereto for Regulatory Approval) (an \u201cNDA\u201d), and (ii) in any country other than the United States, an application or set of applications for Regulatory Approval comparable to an NDA and necessary to make, promote and sell Licensed Product commercially in such country.", "samples": [{"hash": "bBWSnDtsfT8", "uri": "/contracts/bBWSnDtsfT8#marketing-application", "label": "Exclusive License Agreement (Furiex Pharmaceuticals, Inc.)", "score": 21.3641338348, "published": true}, {"hash": "gzrCRKhUUyI", "uri": "/contracts/gzrCRKhUUyI#marketing-application", "label": "Exclusive License Agreement (Furiex Pharmaceuticals, Inc.)", "score": 21.2655715942, "published": true}], "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "licensed-product", "type": "definition", "offset": [25, 41]}, {"key": "in-the-united-states", "type": "clause", "offset": [47, 67]}, {"key": "new-drug-application", "type": "definition", "offset": [71, 91]}, {"key": "the-fda", "type": "clause", "offset": [103, 110]}, {"key": "pursuant-to", "type": "definition", "offset": [111, 122]}, {"key": "section-314", "type": "clause", "offset": [159, 170]}, {"key": "applications-for-regulatory-approval", "type": "clause", "offset": [325, 361]}], "size": 2, "hash": "198acdd8cc10c66a17e18d17ee8ee9ce", "id": 7}, {"snippet": "means an NDA (or its equivalent) submitted to the FDA in the United States, an MAA (or its equivalent) submitted to the EMEA in the European Union, or a corresponding application that has been submitted to a Regulatory Authority in any other jurisdiction.", "samples": [{"hash": "kAJB5j8tYaQ", "uri": "/contracts/kAJB5j8tYaQ#marketing-application", "label": "Development and Commercialization Agreement (Biomarin Pharmaceutical Inc)", "score": 21.0, "published": true}, {"hash": "eUCLFhab8eH", "uri": "/contracts/eUCLFhab8eH#marketing-application", "label": "Development and Commercialization Agreement (La Jolla Pharmaceutical Co)", "score": 21.0, "published": true}], "snippet_links": [{"key": "the-fda", "type": "clause", "offset": [46, 53]}, {"key": "in-the-united-states", "type": "clause", "offset": [54, 74]}, {"key": "the-european-union", "type": "clause", "offset": [128, 146]}, {"key": "regulatory-authority", "type": "definition", "offset": [208, 228]}, {"key": "other-jurisdiction", "type": "definition", "offset": [236, 254]}], "size": 2, "hash": "6008e5b80fa16affdfc46c4845b9cc38", "id": 8}, {"snippet": "means an application for a new drug submitted under section 505(b) of the Act, a request to provide for certification of an antibiotic submitted under section 507 of the Act, or a product license application for a biological product submitted under the Public Health Service Act. 23 EXHIBIT 3.5 INVESTMENT REPRESENTATION LETTER This Investment Representation Letter is delivered in connection with the License Agreement dated May 22, 1996 (the \"License Agreement\") between Southern Research Institute (\"SRI\"), University of Alabama at Birmingham Research Foundation and Corixa Corporation (\"Corixa\"), which, among other things, provides for the sale and issuance to SRI of Fifty Thousand (50,000) shares of Corixa's common stock (the \"Shares\"). The undersigned, in connection with the purchase of the Shares, hereby represents and warrants to Corixa as follows:", "samples": [{"hash": "eMLV2RLWllz", "uri": "/contracts/eMLV2RLWllz#marketing-application", "label": "License Agreement (Corixa Corp)", "score": 18.0, "published": true}, {"hash": "7YQwCaMf3u3", "uri": "/contracts/7YQwCaMf3u3#marketing-application", "label": "License Agreement (Corixa Corp)", "score": 18.0, "published": true}], "snippet_links": [{"key": "new-drug", "type": "definition", "offset": [27, 35]}, {"key": "the-act", "type": "clause", "offset": [70, 77]}, {"key": "provide-for", "type": "definition", "offset": [92, 103]}, {"key": "certification-of", "type": "clause", "offset": [104, 120]}, {"key": "section-507", "type": "clause", "offset": [151, 162]}, {"key": "product-license-application", "type": "definition", "offset": [180, 207]}, {"key": "biological-product", "type": "definition", "offset": [214, 232]}, {"key": "public-health-service-act", "type": "clause", "offset": [253, 278]}, {"key": "investment-representation-letter", "type": "definition", "offset": [295, 327]}, {"key": "in-connection-with", "type": "clause", "offset": [379, 397]}, {"key": "the-license-agreement", "type": "clause", "offset": [398, 419]}, {"key": "research-institute", "type": "definition", "offset": [482, 500]}, {"key": "research-foundation", "type": "definition", "offset": [546, 565]}, {"key": "sale-and-issuance", "type": "clause", "offset": [645, 662]}, {"key": "shares-of", "type": "clause", "offset": [697, 706]}, {"key": "common-stock", "type": "definition", "offset": [716, 728]}, {"key": "the-undersigned", "type": "clause", "offset": [745, 760]}, {"key": "purchase-of-the-shares", "type": "clause", "offset": [785, 807]}], "size": 2, "hash": "0e12dfb60d0c89123fbb9dec1b8a58ec", "id": 9}, {"snippet": "means any application for Regulatory Approval in the Territory or equivalent filings with any Governmental Authority in the Territory, including any updates or supporting Regulatory Filings made with respect thereto.", "samples": [{"hash": "iTrAKmY5KZf", "uri": "/contracts/iTrAKmY5KZf#marketing-application", "label": "Exclusive License and Development Agreement (Cempra, Inc.)", "score": 24.578371048, "published": true}], "snippet_links": [{"key": "regulatory-approval-in-the-territory", "type": "clause", "offset": [26, 62]}, {"key": "or-equivalent", "type": "definition", "offset": [63, 76]}, {"key": "governmental-authority", "type": "definition", "offset": [94, 116]}, {"key": "filings-made", "type": "clause", "offset": [182, 194]}], "size": 2, "hash": "2f9ed4ae33e1e166ac2407950984e3da", "id": 10}], "next_curs": "CmISXGoVc35sYXdpbnNpZGVyY29udHJhY3Rzcj4LEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIebWFya2V0aW5nLWFwcGxpY2F0aW9uIzAwMDAwMDBhDKIBAmVuGAAgAA==", "definition": {"snippet": "means an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.", "title": "Marketing Application", "size": 56, "id": "marketing-application", "examples": ["All of Vetsource\u2019s proprietary software, business processes and expertise provided with the Services, including but not limited to Vetsource Application, Vetsource website, Vetsource eCommerce Home Delivery Shopping Site and Catalog, Email <strong>Marketing Application</strong>, and any others specified in appendices.", "Genzyme shall be responsible, in its sole discretion and at its sole expense, for filing <strong>Marketing Applications</strong> for Aldurazyme in each country, other than as expressly provided in Sections 3.10, 3.11, 3.12 and 5.1.2, in which Aldurazyme is licensed, marketed or sold, up to and including <strong>Marketing Application</strong> Approval, and for thereafter maintaining such <strong>Marketing Application</strong> Approvals.", "Nothing in this Article 5 shall be deemed to require Genzyme to file <strong>Marketing Applications</strong> and obtain <strong>Marketing Application</strong> Approvals in each country in the Territory; Genzyme shall determine in good faith where and when to file and maintain such applications and approvals in a manner consistent with its obligation to use its commercially reasonable and diligent efforts to commercialize Aldurazyme.", "Each of the Company and its subsidiaries has fulfilled its obligations, if any, under the minimum funding standards of Section 302 of the United States Employee Retirement Income Security Act of 1974 (\u201cERISA\u201d) and the regulations and published interpretations thereunder with respect to each \u201cplan\u201d (as defined in Section 3(3) of ERISA and such regulations and published interpretations) in which employees of the Company and its subsidiaries are eligible to participate.", "The following descriptions are hereby added to Exhibit \u201cC-8\u201d of the Service Agreement (the Item Number Descriptions): 3343 2Way-Connect Services \u2014 Set-Up Fee (All Applications Using the FDVS Platform) The charge per 2Way-Connect application (such as, but not limited to, the Fraud Application, the Collections Application or the <strong>Marketing Application</strong>, each being an \u201cApplication\u201d) utilized by RCSI and serviced from the FDVS Platform.", "No later than [***] prior to the anticipated First Commercial Sale of any Cost Share Product and in any event no later than the first filing of a <strong>Marketing Application</strong> for a BLA for such Cost Share Product, the Parties shall form a joint commercialization committee (the \u201cJoint Commercialization Committee\u201d or the \u201cJCC\u201d).", "After the earlier of the first Pre-Approval Inspection by any Regulatory Agency for the Product is completed, or the first <strong>Marketing Application</strong> is submitted, \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 will provide to Dyax as a part of the PQR the number of products introduced that year and their substance category as defined in Appendix D.", "The Manufacturing Lead shall have sole responsibility for preparing the draft of the [*] <strong>Marketing Application</strong> Core Dossier for the United States (the \u201cCMC Core Dossier\u201d).", "All Product supplied by Cayman shall meet (i) the requirements of the QTA, (ii) the current approved Specifications (as referenced in Exhibit A), (iii) additional requirements that the Parties may mutually agree to from time to time if technically feasible and in accordance with the change control procedure set out in the QTA, and (iv) the requirements of any Regulatory Authority to which Aerie has submitted, or notifies Cayman it will submit or sponsor the submission of, a <strong>Marketing Application</strong>.", "Meet or exceed the requirements of its FY22 Cooperative <strong>Marketing Application</strong> to promote travel within and/or to New Mexico through advertising and media efforts as defined in the FY22 Award Summary, as approved by NMTD and attached hereto as Exhibit A."], "related": [["marketing-approval-application", "Marketing Approval Application", "Marketing Approval Application"], ["marketing-approval", "Marketing Approval", "Marketing Approval"], ["regulatory-approval-application", "Regulatory Approval Application", "Regulatory Approval Application"], ["planning-application", "Planning Application", "Planning Application"], ["marketing-authorization-application", "Marketing Authorization Application", "Marketing Authorization Application"]], "related_snippets": [], "updated": "2026-03-14T06:33:37+00:00"}, "json": true, "cursor": ""}}