Subject BLA definition

Subject BLA means BLA Number 125755, approved by the FDA on September 16, 2022 for SKYSONA (elivaldogene autotemcel) for slowing the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
Subject BLA means BLA No. 125690 approved on December 19, 2019, and the subject of Department of Health and Human Services U.S. License No. 0002, issued to Merck with respect to Ebola Zaire Vaccine, Live, which is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.
Subject BLA means BLA Number 125788 for lovotibeglogene autotemcel for patients with Sickle Cell Disease (SCD) 12 years and older with a history of vaso-occlusive events.

Examples of Subject BLA in a sentence

  • In connection with Seller developing the product that is the subject of, and obtaining and maintaining approval of, the Subject BLA, Seller has neither (a) misappropriated the intellectual property of any third party, nor (b) to Seller’s Knowledge, used any data in connection with such activities where Seller did not have sufficient right, title or interest to such data.

  • Seller shall submit the FDA Notification Package to the Subject BLA promptly following Buyer’s notification to Seller of its submission, and Seller’s receipt from Buyer, of a copy of the Buyer Notice of Transfer Submission, but in no event later than 30 days following the Closing (provided that Buyer timely complies with its obligations under this Section 3.04).

  • Within thirty (30) days following the Closing, Xxxxxx agrees, as a courtesy to Buyer and without prejudice to Section 5.06 hereof, that it shall submit the FDA Notification Package to the Subject BLA and, reasonably promptly thereafter, Seller shall provide Buyer with a copy of such submission.

  • No covenant, representation or warranty by 20/20, and no written statement, schedule or certificate furnished or to be furnished by 20/20 pursuant hereto or at the Closing hereunder, contains or will contain any untrue statement of a material fact, or will omit to state a material fact necessary to provide Capital Growth with complete and accurate information as to 20/20 or to make the statements therein not misleading.

  • Seller shall submit the FDA Notification Package to the Subject BLA through the FDA’s Electronic Submission Gateway within 14 days following the Closing and within two (2) days thereafter provide Buyer with a copy of Seller’s submission (the “Seller Notice of Transfer Submission”).


More Definitions of Subject BLA

Subject BLA means BLA No. 125610 approved on December 19, 2017, and the subject of Department of Health and Human Services U.S. License No. 2056, issued to Seller with respect to voretigene neparvovec-rzyl, which is indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Subject BLA means BLA Number 125717, approved by the FDA on August 17, 2022, for ZYNTEGLO (betibeglogene autotemcel) for the treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell transfusions.
Subject BLA means BLA Number 125777 for Chikungunya Vaccine, Live.

Related to Subject BLA

  • Subject Instruments shall nonetheless mean such instrument, agreement or other document, as the case may be, in its entirety, including any portions thereof which shall have been so redacted, deleted or otherwise not filed.

  • Subject Data As used in this section, “subject data” means recorded information, whether or not copyrighted, that is delivered or specified to be delivered as required by the Underlying Agreement. Examples of subject data include, but are not limited to computer software, standards, specifications, engineering drawings and associated lists, process sheets, manuals, technical reports, catalog item identifications, and related information, but do not include financial reports, cost analyses, or other similar information used for performance or administration of the Underlying Agreement.

  • Subject Business means the policy or policies that are

  • Subject Interests means Assignor’s undivided interests in the Subject Lands, as determined prior to giving effect to this Conveyance (or as may be made part of the Subject Interests pursuant to Section 3.1 or 3.2 of the Development Agreement), whether as lessee under leases, as an owner of the Subject Minerals (or the right to extract such Minerals) or otherwise, by virtue of which undivided interests Assignor has the right to conduct exploration, drilling, development and Mineral production operations on the Subject Lands, or to cause such operations to be conducted, or to participate in such operations by paying and bearing all or any part of the costs, risks and liabilities of such operations, to drill, test, complete, equip, operate and produce xxxxx to exploit the Minerals. The “Subject Interests” (a) may be owned by Assignor pursuant to leases, deeds, operating, pooling or unitization agreements, orders or any other instruments, agreements or documents, recorded or unrecorded, (b) include any and all extensions or renewals of leases covering the Subject Lands (or any portion thereof) obtained by Assignor, or any Affiliate thereof, within six (6) months after the expiration or termination of any such lease, and (c) are subject to the Permitted Encumbrances. For the avoidance of doubt, the “Subject Interests” do not include: (i) Assignor’s interests in the Excluded Assets; (ii) Assignor’s rights to substances other than Minerals; (iii) Assignor’s rights to Minerals (other than Assignee Minerals) under contracts for the purchase, sale, transportation, storage, processing or other handling or disposition of Minerals; (iv) Assignor’s interests in, or rights to Minerals (other than Assignee Minerals) held in pipelines, gathering systems, storage facilities, processing facilities or other equipment or facilities, other than Development Xxxxx; or (v) any additional or enlarged interests in the Development Xxxxx, Subject Lands or Subject Minerals acquired by Assignor after the Closing Time, except (1) to the extent any such additional or enlarged interest becomes a part of the Subject Interests by amendment to this Conveyance pursuant to Section 3.1 or 3.2 of the Development Agreement, (2) as may result from the operation of the terms of the instruments creating the Subject Interests, or (3) as may be reflected in extensions and renewals covered by the preceding sentence.

  • Processes with Significant Environmental Aspects means the Equipment which, during regular operation or if not properly operated or maintained, may cause or are likely to cause an adverse effect.

  • Public Improvements means only the following improvements: housing facilities; garbage disposal plants; rubbish disposal plants; incinerators; transportation systems, including plants, works, instrumentalities, and properties used or useful in connection with those systems; sewage disposal systems, including sanitary sewers, combined sanitary and storm sewers, plants, works, instrumentalities, and properties used or useful in connection with the collection, treatment, or disposal of sewage or industrial wastes; storm water systems, including storm sewers, plants, works, instrumentalities, and properties used or useful in connection with the collection, treatment, or disposal of storm water; water supply systems, including plants, works, instrumentalities, and properties used or useful in connection with obtaining a water supply, the treatment of water, or the distribution of water; utility systems for supplying light, heat, or power, including plants, works, instrumentalities, and properties used or useful in connection with those systems; approved cable television systems, approved cable communication systems, or telephone systems, including plants, works,

  • Friable asbestos material means any material that contains more than 1% asbestos by weight and that can be crumbled, pulverized, or reduced to powder when dry, by hand pressure.

  • Subject Invention means any invention of the contractor conceived or first actually reduced to practice in the performance of work under this contract, provided that in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act, 7 U.S.C. 2401(d)) must also occur during the period of contract performance.

  • Covered Environmental Losses means all environmental losses, damages, liabilities, claims, demands, causes of action, judgments, settlements, fines, penalties, costs and expenses (including, without limitation, costs and expenses of any Environmental Activity, court costs and reasonable attorney’s and experts’ fees) of any and every kind or character, by reason of or arising out of:

  • The Properties means and refer to all such existing properties, and additions thereto, as are subject to this Declaration or any Supplemental Declaration under the provisions of Article II hereof.

  • Initial Xxxx of Sale means the document, in the form of Attachment B hereto, executed by an authorized officer of SLM ECFC which shall (i) set forth the applicable Initial Loans offered by SLM ECFC and accepted for purchase by the Interim Eligible Lender Trustee for the benefit of Funding, (ii) sell, assign and convey to the Interim Eligible Lender Trustee for the benefit of Funding and its assignees all rights, title and interest of SLM ECFC in the Initial Loans listed on that Xxxx of Sale and (iii) certify that the representations and warranties made by SLM ECFC as set forth in Sections 5 (A) and (B) of these Master Terms are true and correct.

  • Environmental Information means any information in written, visual, aural, electronic or any other material form on:

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Subject Interest has the meaning assigned to such term in the recitals.

  • Business with which he is associated means any business of which a public servant or his relative is an officer, director, owner, partner, employee or is a holder of more than ten percent (10%) of the fair market value or from which he or his relative derives more than Two Thousand Five Hundred Dollars ($2,500.00) in annual income or over which such public servant or his relative exercises control.

  • Adverse Environmental Condition shall refer to (i) the existence or the continuation of the existence, of an Environmental Emission (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Emission), of, or exposure to, any substance, chemical, material, pollutant, Contaminant, odor or audible noise or other release or emission in, into or onto the environment (including, without limitation, the air, ground, water or any surface) at, in, by, from or related to any Equipment, (ii) the environmental aspect of the transportation, storage, treatment or disposal of materials in connection with the operation of any Equipment or (iii) the violation, or alleged violation of any statutes, ordinances, orders, rules regulations, permits or licenses of, by or from any governmental authority, agency or court relating to environmental matters connected with any Equipment.

  • Oil and Gas Interests means: (a) direct and indirect interests in and rights with respect to oil, gas, mineral and related properties and assets of any kind and nature, direct or indirect, including, without limitation, working, royalty and overriding royalty interests, mineral interests, leasehold interests, production payments, operating rights, net profits interests, other non-working interests, contractual interests, non-operating interests and rights in any pooled, unitized or communitized acreage by virtue of such interest being a part thereof; (b) interests in and rights with respect to Hydrocarbons and other minerals or revenues therefrom and contracts and agreements in connection therewith and claims and rights thereto (including oil and gas leases, operating agreements, unitization, communitization and pooling agreements and orders, division orders, transfer orders, mineral deeds, royalty deeds, oil and gas sales, exchange and processing contracts and agreements and, in each case, interests thereunder), and surface interests, fee interests, reversionary interests, reservations and concessions related to any of the foregoing; (c) easements, rights-of-way, licenses, permits, leases, and other interests associated with, appurtenant to, or necessary for the operation of any of the foregoing; (d) interests in oil, gas, water, disposal and injection xxxxx, equipment and machinery (including well equipment and machinery), oil and gas production, gathering, transmission, compression, treating, processing and storage facilities (including tanks, tank batteries, pipelines and gathering systems), pumps, water plants, electric plants, gasoline and gas processing plants, refineries and other tangible or intangible, movable or immovable, real or personal property and fixtures located on, associated with, appurtenant to, or necessary for the operation of any of the foregoing; and (e) all seismic, geological, geophysical and engineering records, data, information, maps, licenses and interpretations.

  • Purchaser Confidential Information means all confidential or proprietary documents and information concerning the Purchaser or any of its Representatives; provided, however, that Purchaser Confidential Information shall not include any information which, (i) at the time of disclosure by the Company, the Seller Representative or any of their respective Representatives, is generally available publicly and was not disclosed in breach of this Agreement or (ii) at the time of the disclosure by the Purchaser or its Representatives to the Company, the Seller Representative or any of their respective Representatives, was previously known by such receiving party without violation of Law or any confidentiality obligation by the Person receiving such Purchaser Confidential Information. For the avoidance of doubt, from and after the Closing, Purchaser Confidential Information will include the confidential or proprietary information of the Target Companies.

  • Seller Intellectual Property means (a) all Intellectual Property Rights owned or licensed to Seller or its Affiliates prior to the Effective Date; (b) all Intellectual Property Rights in the Seller Parts, the Specifications, and the Base Vehicle; and (c) all other Intellectual Property Rights designed, developed, or otherwise created by Seller or its Affiliates after the Effective Date without reference to Buyer Intellectual Property excluding, in each case, any of the foregoing which are Buyer Intellectual Property.

  • Subject Lands means the lands subject to or covered by the oil and gas leases described in Exhibit A, insofar and only insofar as they cover the Target Formation, subject to the exceptions, exclusions and reservations set forth on such Exhibit A.

  • Intellectual Property Matters Agreement shall have the meaning set forth in the Separation and Distribution Agreement.

  • Public improvement means projects for construction, reconstruction or major renovation on real property by or for a public agency. “Public Works” shall mean roads, highways, buildings, structures and improvement of all types, the construction, reconstruction, major renovation or painting of which is carried on or contracted for by any public agency to serve the public interest by does not include the reconstruction or renovation of privately owned property which is leased by a public agency.

  • Seller Confidential Information has the meaning set forth in Section 6.4.3.

  • After-Acquired Intellectual Property has the meaning assigned to such term in Section 4.02(d).

  • Third Party Agreements means any Contract between or among a Party (or any member of its Group) and any other Persons (other than the Parties or any member of their respective Groups) (it being understood that to the extent that the rights and obligations of the Parties and the members of their respective Groups under any such Contracts constitute Versum Assets or Versum Liabilities, or Air Products Retained Assets or Air Products Retained Liabilities, such Contracts shall be assigned or retained pursuant to Article II).

  • Subject Property means any premises located in the County on which an energy efficiency improvements, water efficiency improvements, or renewable resource applications are being or have been made and financed through an outstanding PACE loan.