Regional Licensed Product definition

Regional Licensed Product means, on a Regional Target-by-Regional Target basis, a [***]
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.
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.

Examples of Regional Licensed Product in a sentence

  • 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.

  • 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).

  • Moreover, each Party and its Related Parties will, using Commercially Reasonable Efforts, be solely responsible for handling all returns of any Regional Licensed Product sold in its Territory, as well as all aspects of Regional Licensed Product order processing, invoicing and collection, distribution, inventory and receivables of Regional Licensed Products sold in its Territory.

  • 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.

  • On a Regional Target-by-Regional Target basis, Novartis will use Commercially Reasonable Efforts to (a) Commercialize each Regional Licensed Product for which Novartis has obtained Regulatory Approval within the Novartis Territory, and (b) perform all Commercialization activities for such Regional Licensed Product in accordance with the RLP Commercialization Strategy.

  • Each Party will submit its RLP Branding Strategy for a Regional Licensed Product to the JCC at least [***] (or more frequently if reasonably requested by the other Party).

  • In addition, each Party will provide the other Party with written notice of the First Commercial Sale of each Regional Licensed Product in such Party’s Territory as soon as reasonably practicable after such event; provided, however, that such Party will inform the other Party of such event prior to public disclosure of such event by such Party.

  • No less than [***] Surface will prepare and deliver to the JCC for review a reasonable written plan that summarizes the Commercialization activities to be undertaken with respect to such Regional Licensed Product in the Surface Territory in the next Calendar Year (the “Surface Territory Commercialization Plan”).

  • If a Party receives any orders for any Regional Licensed Product in the other Party’s Territory, it will refer such orders to the other Party, to the extent it is not prohibited from doing so under applicable Law.


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.

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 any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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 an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • 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 perpetual license to the Software that is identified in the pertaining applicable Order and is subject to the limitations set forth in Sections 1.2.1.2 (Perpetual Licenses) and 1.4 (Use Restrictions).

  • 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 any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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.

  • Reciprocal license means the issuance of an Iowa license to practice barbering to an applicant who is currently licensed in another state and which state has a mutual agreement to license persons who have the same or similar qualifications to those required in Iowa.