Major Market means any one of the following countries: United States, Japan, the United Kingdom, France, Germany, Italy or Spain.
Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.
Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.
Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.
Time for Completion means the time for completing the Works as stated in the Contract Data (or as extended under Sub-Clause 7.3), calculated from the Commencement Date.
Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority having jurisdiction over the applicable activity.
Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.
Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.
Practice of medicine or osteopathic medicine means the prevention, diagnosis and treatment of
Commercialization Plan has the meaning set forth in Section 6.2.
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.
Reporting Period With respect to each Payment Date and for purposes of making calculations with respect to the hypothetical structure and Reference Tranches as set forth in this Agreement:
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
JCC has the meaning set forth in Section 2.1.
Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.
Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.
Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.
Reporting Year means a twelve-month compliance reporting period required under the Applicable Program.
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Registrant Fax Ext 4321 Registrant Email: XXXXX@XXXXXXX.XXX Admin ID: 5372809-ERL Admin Name: EXAMPLE REGISTRANT ADMINISTRATIVE Admin Organization: EXAMPLE REGISTRANT ORGANIZATION Admin Street: 000 XXXXXXX XXXXXX Xxxxx Xxxx: ANYTOWN Admin State/Province: AP Admin Postal Code: A1A1A1 Admin Country: EX Admin Phone: +1.0000000000 Admin Phone Ext: 1234 Admin Fax: +1.5555551213 Admin Fax Ext: Admin Email: XXXXX@XXXXXXX.XXX Tech ID: 5372811-ERL Tech Name: EXAMPLE REGISTRAR TECHNICAL Tech Organization: EXAMPLE REGISTRAR LLC Tech Street: 000 XXXXXXX XXXXXX Xxxx Xxxx: ANYTOWN Tech State/Province: AP Tech Postal Code: A1A1A1 Tech Country: EX Tech Phone: +1.1235551234 Tech Phone Ext: 1234 Tech Fax: +1.5555551213 Tech Fax Ext: 93 Tech Email: XXXXX@XXXXXXX.XXX Name Server: NS01.EXAMPLEREGISTRAR.TLD Name Server: NS02.EXAMPLEREGISTRAR.TLD DNSSEC: signedDelegation DNSSEC: unsigned >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< Registrar Data: Query format: whois “registrar Example Registrar, Inc.” Response format: Registrar Name: Example Registrar, Inc. Street: 0000 Xxxxxxxxx Xxx City: Marina del Rey State/Province: CA Postal Code: 90292 Country: US Phone Number: +1.0000000000 Fax Number: +1.3105551213 Email: xxxxxxxxx@xxxxxxx.xxx WHOIS Server: whois.example-registrar.tld Referral URL: xxxx://xxx.xxxxxxx-xxxxxxxxx.xxx Admin Contact: Xxx Registrar Phone Number: +1.3105551213 Fax Number: +1.3105551213 Email: xxxxxxxxxxxx@xxxxxxx-xxxxxxxxx.xxx Admin Contact: Xxxx Registrar Phone Number: +1.3105551214 Fax Number: +1.3105551213 Email: xxxxxxxxxxxxx@xxxxxxx-xxxxxxxxx.xxx Technical Contact: Xxxx Geek Phone Number: +1.3105551215 Fax Number: +1.3105551216 Email: xxxxxxxx@xxxxxxx-xxxxxxxxx.xxx >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< Nameserver Data: Query format: whois “NS1.EXAMPLE.TLD”, whois “nameserver (nameserver name)”, or whois “nameserver (IP Address)” Response format: Server Name: NS1.EXAMPLE.TLD IP Address: 192.0.2.123 IP Address: 2001:0DB8::1 Registrar: Example Registrar, Inc. WHOIS Server: whois.example-registrar.tld Referral URL: xxxx://xxx.xxxxxxx-xxxxxxxxx.xxx >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< The format of the following data fields: domain status, individual and organizational names, xxxxxxx, xxxxxx, xxxx, xxxxx/xxxxxxxx, postal code, country, telephone and fax numbers (the extension will be provided as a separate field as shown above), email addresses, date and times should conform to the mappings specified in EPP RFCs 5730-5734 so that the display of this information (or values return in WHOIS responses) can be uniformly processed and understood. In order to be compatible with ICANN’s common interface for WHOIS (InterNIC), WHOIS output shall be in the format outline above.
Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.