Common use of Commercialisation Clause in Contracts

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).

Appears in 3 contracts

Samples: Development and Commercialisation Agreement (Dermira, Inc.), Development and Commercialisation Agreement (Dermira, Inc.), Development and Commercialisation Agreement (Dermira, Inc.)

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Commercialisation. 7.1 Except 6.1 Within ninety (90) Business Days of the Effective Date, Licensee shall provide Licensor through the JSC with a preliminary version of its Commercialisation Plan, including the Marketing Plan and Budget for the activities to be conducted by Dermira under the Prefirst year post-Launch Medical Affiairs all of which shall reflect the Launch Commitment and Detailing Commitment. The Marketing Plan as set forth and Budget shall also contain information of the type specified in Section 9.3Schedule 9. Such Commercialisation Plan, Dermira Marketing Plan and Budget shall have no right be updated at least once each Year thereafter and shall be supplied to undertake Dermira Commercial Activities for the Licensor and be reviewed and agreed at a JSC meeting. Where such Commercialisation Plan is updated after Launch of Product in the Promotion Indication Territory, in any country within addition to containing details of Licensee’s proposed plans for Commercialisation, it shall also contain a summary of the Territory unless progress of sales and until UCB has been granted Regulatory Approval to Commercialise the marketing of Product in the Development IndicationTerritory and sales forecasts for the Year covered by the Commercialisation Plan. Such plan shall be received by Licensor subject to the obligations of Clause 18 (Confidentiality). 6.2 Save as specified under Clause 11, unless Licensee shall obtain all of its requirements for Product from Licensor (or as Licensor may direct) on the terms of this Agreement. Within ninety (90) days of the Effective Date the Parties shall enter into a safety and quality agreement covering manufacture of Product (the “Safety and Quality Agreement”) by Licensor (or its nominee) and Licensor shall promptly enter into such Dermira Commercial Activities are identified further agreements or procure execution of the same, by any Party manufacturing the Product for Licensor for supply to Licensee under the terms of this Agreement. Licensor shall procure that each Affiliate of Licensor who is manufacturing Product on behalf of Licensor also enters into the Safety and Quality Agreement if required by Licensee. Notwithstanding any Safety and Quality Agreement entered into between Licensee and any nominees or Affiliates of Licensor, Licensor shall remain solely liable for the performance of its obligations under this agreement and for the performance of any such obligations subcontracted to any such nominee or Affiliate of Licensor. 6.3 Licensee shall exercise its rights under this Agreement as principal and it shall not sell or otherwise dispose of Product on behalf of, or in the Commercialisation Plan name of Licensor or any of Licensor’s Affiliates, provided that to the extent required by applicable law, the name of the Licensor or Licensor’s Affiliates may appear on the packaging of the Product as manufacturer. 6.4 After the NDA Approval Date, Licensee, as the holder of the Initial NDA and without limiting its obligations under this Agreement or under any Applicable Law, shall comply with the content and terms of the Initial NDA; 6.5 Licensee shall maintain in the Territory, as part of its existing scientific service, a scientific service for scientific information relating to be conducted prior the Product and shall liaise with Licensor in relation to any enquiries made 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 Agreementservice. 7.2 Subject 6.6 Licensee shall establish and/or maintain a sales force appointed and trained in accordance with Good Industry Practice 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 promote the Product in the Territory are outside of (provided that it is acknowledged that such sales force shall promote other products with 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 3.4Product).

Appears in 2 contracts

Samples: License and Supply Agreement (Salix Pharmaceuticals LTD), License and Supply Agreement (Salix Pharmaceuticals LTD)

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 If a Party considers there is a potential to Commercialise the Product Project Intellectual Property or other outcomes from the Research Project: the Party must notify the other Parties; and the Parties must confer in good faith and using reasonable efforts to determine if, how and on what terms, to pursue Commercialisation. Each Party: acknowledges the existence and creation of Moral Rights conferred on the Candidate in respect of the Project Results; xxxx immediately notify the other Party in writing upon becoming aware of an infringement or a possible infringement of Moral Rights in relation to Material used or created during the course of the Research Project; will meet to determine in good faith the appropriate steps to undertake to resolve any infringement or potential infringement of Moral Rights relating to material used or created during the course of the Research Project to the satisfaction of the Parties and the Candidate. The University and the Industry Partner will use all reasonable endeavours to respect the Candidate’s Moral Rights in the Development IndicationProject Results, unless such Dermira Commercial Activities are identified the Thesis and any Publications. The Candidate acknowledges the University and the Industry Partner may not be able to always respect the Candidate’s Moral Rights and the Candidate waives and releases the University and the Industry Partner from any Claim for infringement of the Candidate’s Moral Rights due to: the adaptation, revision, addition or deletion of any part of the Thesis or Project Results; the combination of any part of the Project Results with other materials; or any Publication incorporating a part of the Project Results omitting the name of the Candidate. Information sharing and Privacy The University and the Industry Partner acknowledge that in carrying out the Commercialisation Plan as to be conducted prior to such Regulatory Approval. Notwithstanding anything Internship: sharing information with each other under this Agreement is integral to the contrary in this Agreementsuccessful execution of the Candidate’s Internship; the Parties will have access to, Dermira shall have no diligence and will transfer between them, information which may be personal information under the Privacy Laws; and when dealing with the Candidate’s personal information, both Parties must comply with their obligations with respect under the Privacy Laws. The Candidate consents to the Promotion Indication but shall have those rights with respect to disclosure of relevant personal information (including sensitive personal information) between 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 University 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 Industry Partner 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 relevant purposes in connection with such activities this Agreement. Dispute resolution The Parties must not commence any court proceedings relating to any dispute arising from this Agreement (Dispute) unless the process in accordance with Section 3.4)this clause 11 has been followed.

Appears in 1 contract

Samples: Postgraduate Research Internship Tripartite Agreement

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Commercialisation. 7.1 Except 8.1 Licensee shall, either by itself or through its Affiliates, Sublicensees or Third Party contractor(s), be solely responsible for the activities to be conducted by Dermira under Commercialization of 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 Licensed Products in the Promotion Indication in any country within the Territory unless and until UCB has been granted Regulatory Approval to Commercialise the Product Field in the Development IndicationTerritory, unless such Dermira Commercial Activities are identified in at Licensee’s own cost and expense, including developing and executing a commercial launch plan, product marketing and promotion, marketing access and pricing strategy, negotiating with Competent Authorities regarding the Commercialisation Plan as to be conducted prior to such Regulatory Approval. Notwithstanding anything to the contrary in this Agreementprice and reimbursement mechanisms, 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 Agreementbooking sales, product distribution, providing customer support (including handling medical queries), and performing other related functions. 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 Agreement8.2 Licensee either by itself or through its Affiliates, each Sublicensees or Third Party will contractor(s), shall use Commercially Reasonable Efforts to conduct assigned Marketing Commercialize the Licensed Products in each country of the Territory in which it or an Affiliate or Sublicensee receives Regulatory Approval and Corporate Functions Pricing Approval. 8.3 Licensee will have sole authority for determining and activities assigned to it under establishing the Commercialisation Plan price and to Commercialise the terms of sale (including any rebates or discounts) of Licensed Product for each country in the Promotion Territory for Territory. [***]. 8.4 Within [***] prior to the Promotion Indication and the Development Indication, through the coordination anticipated first launch 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 Licensed Product in the Territory, including Licensee will prepare a Commercialization Plan covering: [***]. The Commercialization Plan will be updated [***] by Licensee. The Commercialization Plan, and updates thereto, will be shared with ReViral via the Commercial FunctionsJSC for comment and discussion. 8.5 The Parties shall collaborate with respect to the Commercialization of the Licensed Products across their respective territories. Through the JSC, ReViral shall remain under the sole responsibility and control keep Licensee reasonably informed of UCB, except for activities delegated to Dermira under the Commercialisation Plan and/or Medical Affairs Plan its plans (including any updates and amendment thereto) for the right global Commercialization of the Licensed Products in sufficient detail for Licensee to engage Third Party contractors make related updates to align Commercialization of the Licensed Products in connection the Territory with ReViral’s global Commercialization plans, provided that any such update will be in Licensee’s sole discretion. 8.6 The Parties recognize that they may benefit from the coordination of certain activities in support of the Commercialization of the Licensed Products across their respective territories. As such, the Parties may coordinate such activities where appropriate, including scientific and medical communication and product positioning. If the Parties wish to jointly conduct any specific Commercialization activities for the benefit of the Licensed Products in accordance both Parties’ territories, the Parties may negotiate and agree on the details of such activities, including allocation of responsibilities, budget and cost sharing. 8.7 Licensee or its Affiliates or Sublicensees will have sole authority, consistent with Section 3.4the Commercialization Plan, for the creation, preparation, production and reproduction of all promotional materials relating to Licensed Products in the Territory and for filing, as may be required, such promotional materials with Regulatory Authorities in the Territory. 8.8 Licensee shall not make any medical or promotional claims for any Licensed Product other than as permitted by Applicable Laws. When distributing information related to any Licensed Product or its use in the Territory (including information contained in scientific articles, reference publications and publicly available healthcare economic information), Licensee must comply with all Applicable Laws in the applicable country in the Territory. 8.9 Licensee shall keep the JSC reasonably informed of its, its Affiliates’ and Sublicensees’ Commercialization activities with respect to the Licensed Products. Without limiting the foregoing, Licensee shall update the JSC at least [***] at each [***] regarding the Commercialization activities with respect to the Licensed Products in the Territory. Each such update shall be in a form to be agreed by the JSC and shall summarize Licensee’s, its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to the Licensed Products in the Territory. In addition, Licensee shall make available to the JSC such additional information about its Commercialization activities as may be reasonably requested by the JSC from time to time.

Appears in 1 contract

Samples: Co Development and License Agreement (LianBio)

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