Commercialisation. 7.1 Except for the activities to be conducted by Dermira under the Pre-Launch Medical Affiairs Plan as set forth in Section 9.3, Dermira shall have no right to undertake Dermira Commercial Activities for the Product in the Promotion Indication in any country within the Territory unless and until UCB has been granted Regulatory Approval to Commercialise the Product in the Development Indication, unless such Dermira Commercial Activities are identified in the Commercialisation Plan as to be conducted prior to such Regulatory Approval. Notwithstanding anything to the contrary in this Agreement, Dermira shall have no diligence obligations with respect to the Promotion Indication but shall have those rights with respect to the Promotion Indication as set forth in this Agreement.
7.2 Subject to the restriction on the Dermira Commercial Activities for the Product in the Promotion Indication and Development Indication in the Promotion Territory referred to in this Agreement, each Party will use Commercially Reasonable Efforts to conduct assigned Marketing and Corporate Functions and activities assigned to it under the Commercialisation Plan and to Commercialise the Product in the Promotion Territory for the Promotion Indication and the Development Indication, through the coordination of the JCT and under the oversight of the JCC and the JSC. All other aspects of the Commercialisation of the Product in the Territory are outside of the scope of this Agreement and shall remain under the responsibility and control of UCB.
7.3 It is the Parties’ intent for Dermira to be the Party primarily responsible for the Dermira Commercial Activities in connection within the Promotion Indication and the Development Indication and solely to Dermatologists in the Promotion Territory, subject to the JCC approving all activities and UCB approving all Promotional Materials developed by Dermira. In addition, Dermira shall have the right to perform the Medical Affairs activities under the approved Medical Affairs Plan or otherwise permitted under Section 9. All other aspects of the Commercialisation of the Product in the Territory, including the Commercial Functions, shall remain under the sole responsibility and control of UCB, except for activities delegated to Dermira under the Commercialisation Plan and/or Medical Affairs Plan (including the right to engage Third Party contractors in connection with such activities in accordance with Section 3.4).
Commercialisation. A party may only Commercialise or disseminate the Project IP with the prior written consent of the other party. Any Commercialisation of Project IP will be subject to a separate commercialisation agreement as agreed between the parties. Privacy & Data The Research Organisation must: comply with the Privacy Xxx 0000 (Cth) and all other applicable privacy laws as may be in force from time to time which regulate the collection, storage, use and disclosure of information, including the Australian Privacy Principles; not disclose any Personal Information under or in connection with this Agreement to any entities located outside of Australia without MLA's prior written consent; and ensure that all of its subcontractors or agents comply with this clause 11.1. Without limiting clause 11.1: where the Research Organisation collects Personal Information for or on behalf of MLA, the Research Organisation: must only use and disclose that information for the purpose for which it is collected; and must not publish, disseminate or Commercialise the Personal Information in any way; in relation to any Personal Information that the Research Organisation provides to MLA under this Agreement, the Research Organisation warrants that it has: before providing the Personal Information to MLA, notified all individuals to whom the Personal Information relates that it will be disclosing their Personal Information to MLA for the purposes of the Project and obtained any required consent to such disclosure; and provided the individuals with the location of where the privacy policy of MLA or ISC (as applicable) can can be found, which is via MLA Privacy Policy or ISC Privacy Policy respectively. at; in relation to any Personal Information provided to the Research Organisation by MLA under this Agreement, the Research Organisation must: only store, use, disclose or otherwise handle the information for the specific purposes for which it was provided to the Research Organisation under this Agreement; and co-operate with any reasonable request or direction of MLA which relates to the protection of the information; and the Research Organisation must promptly notify MLA of any complaint that it receives concerning the Personal Information under this Agreement.
Commercialisation. All business decisions, including but not limited to the selection of the trademark(s) for Product, pricing, reimbursement, package design, sales and promotional activities and the decision to launch or continue to market a Product in a particular country in the Territory, shall be within the sole discretion and responsibility of THERAVANCE. Notwithstanding the above it is agreed that THERAVANCE shall otherwise use reasonable efforts consistent with its normal business practices to market and promote Product. In doing so it will use the same level of effort as with its other, similar products of similar sales potential. Failure to use reasonable efforts as qualified herein can be considered a material breach in accordance with the provisions of Article 14.1.
Commercialisation. 5.1 Subject to Clause 5.16, Almirall’s core obligation in relation to Commercialisation of Product shall be to use its Commercially Reasonable Efforts to achieve Launch of the Product for the first Indication within six (6) months after the grant of Marketing Authorisation (including pricing and/or reimbursement approval where such approval is necessary or industry practice for Launch) for Product for that Indication in each Major European Market and in the other countries in the Territory. Thereafter Almirall shall use its Commercially Reasonable Efforts in each Major European Market and in the other countries in the Territory to realise the market potential of Product for that Indication and any subsequent Indication for which GW Pharma obtains a Marketing Authorisation save as provided below:
5.1.1 As soon as Almirall considers that there is no economic case for launching Product in a specific country in the Territory and in any event within six (6) months of Marketing Authorisation for that country being granted, Almirall shall give GW Pharma written notice of this opinion and include evidence in Document form to support this opinion;
5.1.2 If GW Pharma agrees with Almirall’s opinion Almirall shall be relieved of its obligation to use Commercially Reasonable Efforts to Commercialise Product in the country in question;
5.1.3 If GW Pharma disagrees with this opinion, the Parties shall timely perform a joint evaluation of the marketing opportunity in the country in question to resolve the economic case for Launching Product in such country. If having conducted such evaluation:
(i) The Parties agree that there is an economic case for launching in a country but that Almirall does not wish to do so itself or on its own behalf, the Parties shall either:
(a) agree a plan to jointly Commercialise Product for that indication in the country in question, in which case the Parties shall negotiate a change to the terms of this Agreement with regard to Commercialisation of Product in the country in question to reflect GW Pharma’s increased role; or if no agreement under this Clause 5.1.3(i)(a);
(b) GW Pharma, in its absolute discretion, may elect to take over Commercialisation of Product in said country, in which case the right granted to Almirall under Clause 2.1 shall be deemed not to include the country in question and GW Pharma shall have the right to Commercialise Product for that Indication in
Commercialisation. The obligations of each of the Parties in respect of commercialisation will be as contained in the relevant Commercialisation Licence or Complementary Agreement (if any).
Commercialisation. In cases of commercialisation where tendering will be part of the process, the members of the joint WFA-ASD committee shall make every reasonable effort to come to an agreement on the criteria related to human resources issues (e.g. terms and conditions of employment, pension and health care benefits, the take-up number of employees) to be used in the request for proposal (RFP) process. The committee will respect the contracting rules of the federal government.
Commercialisation. The Licensee shall use Diligent and Reasonable Efforts to develop and commercially exploit the Patents in the Territory.
Commercialisation. 9.1 For each Qualifying Product in the Territory, Sanofi will have the sole right, in its discretion, to Commercialise any Qualifying Molecule or Qualifying Product in the Territory.
9.2 For each Calendar Year from and including the Calendar Year in which the First Commercial Sale of any Qualifying Small Molecule Product occurs, together with the first Royalty Report that is delivered after the end of each such Calendar Year, Sanofi shall provide [***]. Other than as prohibited by Applicable Law or Third Party confidentiality obligations, in the event of any material deviation from the planned Commercialisation activities to be performed by Sanofi, its Affiliates and Sublicensees, Sanofi shall update [***].
Commercialisation. (a) The Licensee shall use commercially reasonable endeavours to develop a Complement Factor I therapy.
(b) [**]
Commercialisation. Celldex shall use Diligent and Reasonable Efforts to develop and commercially exploit at least one Licensed Product in the Field and Territory.
