Clinical Supply Servier shall be primarily responsible for manufacturing and supplying bulk Licensed Oligos and finished Licensed Products for use in clinical studies conducted pursuant to the Development Plan in the Field in the Territory, provided that Servier may engage Miragen for such manufacture and supply as follows: At least 180 days prior to the anticipated filing of the first CTA for the first indication with respect to a Licensed Product, Servier shall notify Miragen in writing whether it desires to engage Miragen for such manufacture and supply. If Servier chooses to have Miragen provide such clinical supply, Servier and Miragen shall negotiate in good faith and enter into a separate supply agreement having mutually agreed terms with respect to such clinical supply, which supply shall be at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]). For clarity, Miragen’s manufacturing-related Development costs, as described in Section 1.27(e), [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. are not included in the Cost of Goods but shall be included in Development Plan Costs and shared by the Parties pursuant to Section 9.3. If Servier does not engage Miragen but elects to manufacture and supply bulk Licensed Oligos and finished Licensed Products for Development purposes, either through itself or its Third Party manufacturer, then Miragen shall have the right to purchase such bulk Licensed Oligos and finished Licensed Products from Servier at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]), and the other terms and conditions to be agreed upon by the Parties and set forth in a separate supply agreement. For clarity, Miragen shall have the right to manufacture and have manufactured, anywhere in the world, the Licensed Oligos and Licensed Products for clinical and commercial use outside the Territory.
PROPOSED MOBILITY PROGRAMME The proposed mobility programme includes the indicative start and end months of the agreed study programme that the student will carry out abroad. The Learning Agreement must include all the educational components to be carried out by the student at the receiving institution (in table A) and it must contain as well the group of educational components that will be replaced in his/her degree by the sending institution (in table B) upon successful completion of the study programme abroad. Additional rows can be added as needed to tables A and B. Additional columns can also be added, for example, to specify the study cycle-level of the educational component. The presentation of this document may also be adapted by the institutions according to their specific needs. However, in every case, the two tables A and B must be kept separated, i.e. they cannot be merged. The objective is to make clear that there needs to be no one to one correspondence between the courses followed abroad and the ones replaced at the sending institutions. The aim is rather that a group of learning outcomes achieved abroad replaces a group of learning outcomes at the sending institution, without having a one to one correspondence between particular modules or courses. A normal academic year of full-time study is normally made up of educational components totalling 60 ECTS* credits. It is recommended that for mobility periods shorter than a full academic year, the educational components selected should equate to a roughly proportionate number of credits. In case the student follows additional educational components beyond those required for his/her degree programme, these additional credits must also be listed in the study programme outlined in table A. When mobility windows are embedded in the curriculum, it will be enough to fill in table B with a single line as described below: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Mobility window … Total: 30 Otherwise, the group of components will be included in Table B as follows: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Course x … 10 Module y … 10 Laboratory work … 10 Total: 30 The sending institution must fully recognise the number of ECTS* credits contained in table A if there are no changes to the study programme abroad and the student successfully completes it. Any exception to this rule should be clearly stated in an annex of the Learning Agreement and agreed by all parties. Example of justification for non-recognition: the student has already accumulated the number of credits required for his/her degree and does not need some of the credits gained abroad. Since the recognition will be granted to a group of components and it does not need to be based on a one to one correspondence between single educational components, the sending institution must foresee which provisions will apply if the student does not successfully complete some of the educational components from his study programme abroad. A web link towards these provisions should be provided in the Learning Agreement. The student will commit to reach a certain level of language competence in the main language of instruction by the start of the study period. The level of the student will be assessed after his/her selection with the Erasmus+ online assessment tool when available (the results will be sent to the sending institution) or else by any other mean to be decided by the sending institution. A recommended level has been agreed between the sending and receiving institutions in the inter-institutional agreement. In case the student would not already have this level when he/she signs the Learning Agreement, he/she commits to reach it with the support to be provided by the sending or receiving institution (either with courses that can be funded by the organisational support grant or with the Erasmus+ online tutored courses). All parties must sign the document; however, it is not compulsory to circulate papers with original signatures, scanned copies of signatures or digital signatures may be accepted, depending on the national legislation. * In countries where the "ECTS" system it is not in place, in particular for institutions located in partner countries not participating in the Bologna process, "ECTS" needs to be replaced in all tables by the name of the equivalent system that is used and a weblink to an explanation to the system should be added. The section to be completed during the mobility is needed only if changes have to be introduced into the original Learning Agreement. In that case, the section to be completed before the mobility should be kept unchanged and changes should be described in this section. Changes to the mobility study programme should be exceptional, as the three parties have already agreed on a group of educational components that will be taken abroad, in the light of the course catalogue that the receiving institution has committed to publish well in advance of the mobility periods and to update regularly as ECHE holder. However, introducing changes might be unavoidable due to, for example, timetable conflicts. Other reasons for a change can be the request for an extension of the duration of the mobility programme abroad. Such a request can be made by the student at the latest one month before the foreseen end date. These changes to the mobility study programme should be agreed by all parties within four to seven weeks (after the start of each semester). Any party can request changes within the first two to five-week period after regular classes/educational components have started for a given semester. The exact deadline has to be decided by the institutions. The shorter the planned mobility period, the shorter should be the window for changes. All these changes have to be agreed by the three parties within a two-week period following the request. In case of changes due to an extension of the duration of the mobility period, changes should be made as timely as possible as well. Changes to the study programme abroad should be listed in table C and, once they are agreed by all parties, the sending institution commits to fully recognise the number of ECTS credits as presented in table C. Any exception to this rule should be documented in an annex of the Learning Agreement and agreed by all parties. Only if the changes described in table C affect the group of educational components in the student's degree (table B) that will be replaced at the sending institution upon successful completion of the study programme abroad, a revised version should be inserted and labelled as "Table D: Revised group of educational components in the student's degree that will be replaced at sending institution". Additional rows and columns can be added as needed to tables C and D. All parties must confirm that the proposed amendments to the Learning Agreement are approved. For this specific section, original or scanned signatures are not mandatory and an approval by email may be enough. The procedure has to be decided by the sending institution, depending on the national legislation.
Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge Supply Price for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing.
5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge Supply Price for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing.
5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2.
5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5.
5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense:
(a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date.
(b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan.
5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).