Project Cooperation – Management Regulations
South China Center for Innovative Pharmaceuticals (“SCCIP”)
Management Regulation for Research and Development of Co-development Projects
(Issued on October 12, 2010)
Chapter I General Provisions
Article 1 In order to regulate the management of the co-development projects (hereinafter referred to as “co-development projects”) of theSouth China Center for Innovative Pharmaceuticals (hereinafter referred to as “SCCIP”)and ensure the application, evaluation and management of the co-development projects to be processed in the fair and just, scientific and reasonable as well as orderly and efficient manner so as to effectively control risks of the co-development projects, we have stipulated this regulation in accordance with the Regulation of the South China Center for Innovative Pharmaceuticals.
Article 2 The co-development projects mentioned herein refer to the projects developed by SCCIP jointly with the project owners through fund investment and technical services for R&D. SCCIP will benefit from the outcome in forms of benefits and fixed return after the projects progresses. The project owners can be individual, R&D unit or company.
Article 3 The range of co-development projects indicated here include new drugs (including chemical drugs, TCM and bioproducts) at any R&D stage from nonclinical research to obtaining a production license, or in viro biomarker diagnostic reagents or new medical devices in the development stage.
Article 4 SCCIP has the obligation to keep confidential the contents of the co-development projects while the project owner is responsible for the authenticity of the project in application as well as data in his/her research.
Article 5 The Project Development Department of SCCIP is in charge of the implementation of the whole co-development project.
Chapter II Project Collection
Article 6 Under the principle of “open collection, two-way selection, sincerely and fairly cooperation, risk and benefit sharing”, SCCIP collects co-development projects all over the world. The project owner could be any entity or individual.
Article 7 SCCIP collects the co-development projects openly all year around, the project owner could directly submit the cooperation intention in accordance with relevant requirements at any time.
Article 8 An assigned staff in the Project Development Department is responsible for collecting and confirming the application documents of the potential co-development projects and to keeping contact with the project owners afterward.
Chapter III Preliminary Screening of Projects
Article 9 The Project Development Department irregularly holds the meeting on projectpreliminary screening based on the number of the project documents.
Article 10 The preliminary screening aims to determine if the project documents submitted meets the requirement of the technical assessment, if the project submitted is conformable to the scope and the principle of cooperation. The project passing the preliminary screening will enter the technical assessment stage.
Chapter IV Technology Assessment
Article 11 SCCIP establishes the Project Assessment Committee responsible for evaluating the co-development projects which pass the preliminary screening
Article 12 The Project Assessment Committee consists of SCCIP experts and external experts. Vice-director of SCCIP in charge of the project managementact as thechair of the Project Assessment Committee. The SCCIP involved experts include the vice-director in charge of the project management and the director of the Project Development Department. The external experts cover 5-7 renowned researchers of whom 2-3 experts come from the shareholders of SCCIP (-by turns), and the remaining 3-5 from medical industry and organizations in Guangdong Province. The external experts are randomly selected by the Project Development Department from the relevant expert bank of SCCIP prior to the meeting.
Article 13 The Project Assessment Committee aperiodically holds the assessment meeting for the applied projects according to the chair’s proposal
Article 14 The project assessments should abide by the following principles:
1. Druggability: mainly assess the risk of being marketed in China for the co-development project including checking if the basis of the development of the project is fully presented and if the R&D is conformable to the requirements of the latest new Drug Registration Regulation , and so forth;
2. Originality: the co-development project shall be characterized by its creativity, especially having its obvious superiority in clinical applications with clearly protection on intellectual property;
3. Maturity: the project maturity shall be considered in the different stage of R&D of the projects，the priority in recent time will be granted to the co-development projects having the official approval from SFDA for conducting clinical trial.
4. marketability: the co-development projects shall show their industrialization prospective outlook to meet the need in future market.
Article 15 Summary of each meeting on evaluation must be concluded. The Project Development Department must write a report on the technical evaluation, making conclusion on the preliminary technical evaluation and putting forward a proposal for each co-development project after the evaluation meeting.
Article 16 The technical evaluation conclusion and proposal are divided into two categories as follows:
1. if the applied project meets the related requirements on technical evaluation, it can enter commercial negotiation stage;
2. quitting evaluation if the relative requirements on technical evaluation are not satisfied;
Suspend the evaluation if if the applied project meets the related requirements on technical evaluation
Article 17 The applied projects that meet the requirement of Article 16 Item 1 go further for commercial negotiation; or all application documents will be filed and then suspend the evaluation if the project submitted is conformable to Article 16 Item 2.
Article 18 The technical evaluation report comes into effect after examined and approved by vice-director in question of SCCIP.
Chapter V Commercial Negotiation
Article 19 The Project Development Department is responsible for organizing the commercial negotiation for co-development projects
Article 20 The commercial negotiation regulations are drawn up separately. .
Chapter VI Signing Agreement
Article 21 The draft of Cooperation Agreement is reviewed by the SCCIP director meeting.
Article 22 After being reviewed and passed at the SCCIP director meeting，the Cooperation Agreement is signed by the SCCIP legal representative and the project owner .
Chapter VII Project Management
Article 23 After the Cooperation Agreement between SCCIP and project owner has been signed, the project owner, act as a project partner participate in the follow-up R&D, and the co-development project is managed as required in this chapter.
Article 24 The Project Development Department will supervise each item stipulated on the Cooperation Agreement so as to firmly promote the R&D of the project in question.
Article 25 The co-development project management covers the following process:
1. Coordination with each unit and each department during R&D;
2. Supervisionon R&D fund paid by SCCIP;
3. Organization of the meeting on the project R&D at each stage
Article 26 The project manager has overall responsibility for the management of co-development projects. The project manager is usually a managerial staff in the project development department, or a person from outside if necessary.
Article 27 An appointed project manager for each project is responsible for the routine supervision on the project；the detailed management plan is formulated for each project, and the project manager execute the plan.
Article 28 :The main responsibilities of the project senior manager and the project manager
1. The project senior manager is responsible for assigning a project manager, reviewing the management plan, supervising and coordinate the work of different project managers.
2. The project manager is responsible for management as whole in implementation of the Cooperation Agreement:
（1） Formulating managerial plan for co-development projects;
（2） Participating in R&D plan formulation, and organizing an R&D plan review if necessary;
（3） Reviewing expenditure reasonability of R&D budget, and help financial staff to pay R&D fund based on the management plan;
（4） Organizing stage assessment for co-development projects according to project management plan and presenting the proposal;
（5）Communicating with the principal in charge of R&D, finding in time and solving coordinately theproblems during R&D.
Article 29 The project management plan is formulated according to Cooperation Agreement, at least including the contents as follows:
1. Major R&D contents;
2. Schedule of R&D;
3. The budget arrangement, including the amount, usage, allocation schedule, and the information about the user, etc.;
4. 研发的阶段性技术评估日程计划；
4. Schedule on technical evaluation of R&D in stage;
5. Others needed to illustrate.
Article 30 The project management plan is reviewed by the project senior manager and director of the Project Development Department and comes into effect after approval by the vice-director of SCCIP in charge of the project management.
Article 31 Any modification of the project management plan shall be reported upon submission in written form to indicate the reason of such a modification for approval by the project director and director of the project development department such that the modified plan would come into effect upon approved by the vice-director of SCCIP concerned.
The written report about the reason for any modification of the project management plan needs to be reviewed by the project senior manager and director of the Project Development Department and comes into effect after approval by the vice-director of SCCIP in charge of the project management.
Article 32 The project manager needs to participate in discussion on major R&D plan of co-development project in his/her charge. For R&D projects with fund investment by SCCIP the R&D plan must be reviewed if necessary.
Article 33 The fund invested by SCCIP is managed in accordance with the following principles:
1. Fund quota shall be executed according to Cooperation Agreement. In case that more money is added into the quota due to some reasons, it needs to be reviewed by SCCIP Director meeting. The legal representative and project owner sign a complementary agreement to confirm the new fund quota invested if the addition of money is sanctioned.
2. The fund management follows the principle of paying by installment or paying directly. Paying by installment means allocation is made in accordance with the project management plan, and the decisions is made by the project assessment, namely the R&D fund for next stage is not paid before the project passes the stage assessment . Paying directly means that all funds are directly allocated to R&D implementing entities according to the project management plan.
Article 34 A decision can be made by the project stage assessment as to whether to commit to and authorize the project to proceed.
Article 35 The partner need present the complete R&D documents and the report on the result of the stage R&D to SCCIP.
Article 36 The project manager is responsible for organizing the stage assessment. The assessment group consisting of 3 renowned experts in relevant stage of R&D and SCCIP staffs involved reviews and discusses the on-going status of the project from these aspects as follows: if the expected goal is achieved, if the risk of the follow-up R&D is under control, the safety and efficiency of the on-going project is within the accepted range
Article 37 The project manager drafts out the stage assessment report according to R&D evaluation summary report, analyzes whether the R&D of the co-development project proceeds, and makes proposals either to proceed, or to suspend the project.. The stage assessment report needs to be submitted to the director of the Project Development Department for review and the stage assessment report goes into effect after approved by the vice-Director of SCCIP in question upon further submission.
Article 38 Any project that fails to pass the evaluation upon analysis on the R&D results is not suitable to be as the co-development project for further R&D, which needs to be reviewed at the SCCIP director meeting and the Cooperation Agreement is suspended upon approval signed by the director of SCCIP.
Article 39 After the stage R&D results are analyzed and summarized, a decision can be made for the co-development projects that can be considered to be further proceededas to authorize the project to proceed until the contents of the agreement is completed.
Chapter VIIISupplementary Articles
Article 40 The regulation is interpreted by the Project Development Department.
Article 41 The regulation will come into effect as of the date of its promulgation.
附件1：合作研发项目管理流程图
Annex 1: Flow chart of management of co-development projects
附件2：《合作研发项目信息表》
Annex 2: Information Sheet of Co-development Project
