Regional Licensed Product definition

Regional Licensed Product means, on a Regional Target-by-Regional Target basis, a [***]
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Regional Licensed Product means (i) ALN-TTR02 as of the Effective Date, and (ii) if Genzyme exercises a Regional Option for any Regional Option Product, then such Regional Option Product as of the applicable Option Exercise Date, in each case for as long as the Regional License Terms applies to ALN-TTR02 or any such Regional Option Product.
Sample 1
Regional Licensed Product means: (i) ALN-TTR02 as of the Effective Date and (ii) if Genzyme exercises the Regional Option pursuant to the Master Agreement for any Regional Option Product, then such Regional Option Product as of the applicable Option Exercise Date. For the sake of clarity (but not for purposes of interpretation of the Collaboration Agreement), although ALN-TTRsc is not a Regional Licensed Product, it is exclusively licensed to Genzyme in the Genzyme Territory in much the same way that Regional Licensed Products are licensed to Genzyme in the Genzyme Territory under these Regional License Terms. As a Co-Co Licensed Product, however, ALN-TTRsc is licensed to Genzyme under the Co-Co License Terms, which also grant Genzyme a license to co-Commercialize ALN-TTRsc in the Alnylam Territory.
Sample 1

Examples of Regional Licensed Product in a sentence

  • The fair value of our debt securities listed below are based on quoted market prices.

  • Each Party will have the sole right to (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority in its Territory with respect to such Regional Licensed Product; (ii) interface, correspond and meet with each Regulatory Authority in its Territory with respect to such Regional Licensed Product, and (iii) seek and maintain all regulatory filings in its Territory with respect to such Regional Licensed Product.

  • Each Party, in consultation with the other Party, will decide whether to conduct a recall of a Regional Licensed Product in its own Territory and the manner in which any such recall will be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but will notify the other Party as soon as possible thereafter).

  • Each Party will provide the other Party with reasonable advance notice of all substantive meetings with the Governmental Authorities in its Territory pertaining to each Regional Licensed Product, or with as much advance notice as practicable under the circumstances.

  • Novartis will be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant Promotional Materials relating to each Regional Licensed Product for use in the Novartis Territory.

  • Each Party will provide such other information to the JCC as the other Party may reasonably request with respect to Commercialization of such Regional Licensed Product and will keep such JCC reasonably informed of such Party’s Commercialization activities with respect to such Regional Licensed Product.

  • The Parties will establish a committee, no later than completion of the first Phase 2 Clinical Study for the first Regional Licensed Product, to (a) oversee Commercialization of Regional Licensed Products in the Territory, and (b) facilitate the flow of information between the Parties with respect to, and provide a forum to discuss, the Commercialization of T1 Antibody Candidates, T1 Licensed Products, Global Antibody Candidates and Global Licensed Products (the “JCC”).

  • All such Promotional Materials will be compliant with applicable Law and, if applicable, consistent in all material respects with the Surface Territory Commercialization Plan and, if applicable, consistent in all material respects with the RLP Branding Strategy for such Regional Licensed Product in the Surface Territory.

  • Notwithstanding the foregoing, in the event of any disagreement between the Parties regarding the Novartis Territory Commercialization Plan for a Regional Licensed Product pursuant to Section 2.5.5, the Novartis representatives on the JCC will have final decision-making authority over the preparation and updating of such Novartis Territory Commercialization Plan, provided that such decisions do not materially adversely affect the Commercialization of such Regional Licensed Product in the Surface Territory.

  • Each Party will notify the JDC, including a brief description in English, of the principal issues raised in each material communication with Regulatory Authorities with respect to such Regional Licensed Product within [***] after receipt thereof.


More Definitions of Regional Licensed Product

Regional Licensed Product means, on a Regional Target Pair-by-Regional Target Pair basis, a product containing or comprising (or using as part of a Combination Product) a Regional Licensed Antibody as an active ingredient, and all formulations, dosages and delivery systems thereof; provided that, a Regional Licensed Product does not include any Antibodies, compounds or products of Xencor or any of its Affiliates other than the Regional Licensed Antibody contained in or comprising such Regional Licensed Product.
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Related to Regional Licensed Product

  • Professional license means any license, permit, certificate, registration, qualification, admission, temporary license, temporary permit, temporary certificate, or temporary registration that is described in divisions (W)(1) to (37) of this section and that qualifies a person as a professionally licensed person.

  • Commercial License means any license issued to an individual or entity that is not a patient, caregiver, or transporter agent.

  • Retail license means one of the following licenses issued under this title:

  • Occupational license means a certificate, registration, or license issued by a state department, bureau, or agency that has regulatory authority over an individual that allows an individual to legally engage in a regulated occupation or that allows the individual to use a specific title in the practice of an occupation, profession, or vocation.

  • Provisional license means a nonrenewable license issued by the Board of Education for a specified

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Conditional license or "conditional approval" means a license

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Initial license means the first permanent license granted to a qualified individual.

  • Licensed Territory means worldwide.

  • Original license means a motor vehicle dealer license issued to an applicant who has never been

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • Local licensing authority means the governing body of a municipality or city and county, the board of county commissioners of a county, or any authority designated by municipal or county charter, municipal ordinance, or county resolution.

  • Perpetual License means a license which is everlasting and valid if the software is being used in accordance with the license-agreement requirements.

  • Licensed Field means [***].

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Exclusive Territory means (1) the states of Illinois, Wisconsin, and Indiana; and

  • Territory means worldwide.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.