([***]) DAYS IN DURATION, THAT IS CONDUCTED IN
COMPLIANCE WITH GLP AND IS REQUIRED TO MEET THE REQUIREMENTS FOR FILING AN IND.
1.33.
"GLP" OR "GOOD LABORATORY PRACTICE" MEANS CURRENT GOOD LABORATORY
PRACTICE STANDARDS PROMULGATED OR ENDORSED BY THE FDA AS DEFINED IN 21 C.F.R.
PART 58, OR ANY COMPARABLE REGULATORY STANDARDS IN ANY COUNTRY OTHER THAN THE
UNITED STATES.
1.34.
"IND" OR "INVESTIGATIONAL NEW DRUG APPLICATION" MEANS AN
INVESTIGATIONAL NEW DRUG APPLICATION FILED WITH THE FDA IN THE UNITED STATES OR
ANY EQUIVALENT COUNTERPART IN ANY COUNTRY OTHER THAN THE UNITED STATES,
INCLUDING ALL SUPPLEMENTS AND AMENDMENTS THERETO.
1.35.
"INDICATION" MEANS ANY HUMAN DISEASE OR CONDITION, OR SIGN OR
SYMPTOM OF A HUMAN DISEASE OR CONDITION.
1.36.
"INITIATION" MEANS, WITH RESPECT TO A CLINICAL TRIAL, THE FIRST
DOSING OF THE FIRST PATIENT ENROLLED IN SUCH CLINICAL TRIAL WITH A LICENSED
PRODUCT; AND WITH RESPECT TO A GLP TOXICOLOGY STUDY, THE FIRST DOSING OF THE
FIRST MAMMAL IN SUCH STUDY.
1.37.
"JOINT INTELLECTUAL PROPERTY" MEANS THE JOINT KNOW-HOW AND JOINT
PATENT RIGHTS.
1.38.
"JOINT KNOW-HOW" MEANS KNOW-HOW THAT IS DEVELOPED BY ONE OR MORE
EMPLOYEES, AGENTS OR CONSULTANTS OF SYNTA OR ANY OF ITS AFFILIATES, ON THE ONE
HAND, AND ONE OR MORE EMPLOYEES, AGENTS OR CONSULTANTS OF ROCHE OR ANY ONE OF
ITS AFFILIATES, ON THE OTHER HAND, IN THE CONDUCT OF RESEARCH, DEVELOPMENT,
MANUFACTURING OR COMMERCIALIZATION OF COLLABORATION COMPOUNDS, LICENSED
COMPOUNDS OR LICENSED PRODUCTS, INCLUDING JOINT INVENTIONS.
1.39.
"JOINT PATENT RIGHTS" MEANS ALL PATENT RIGHTS THAT CLAIM OR
DISCLOSE JOINT KNOW-HOW.
1.40.
"KNOW-HOW" MEANS ANY INFORMATION AND MATERIALS, WHETHER PATENTABLE
OR NOT, INCLUDING (A) IDEAS, DISCOVERIES, INVENTIONS, IMPROVEMENTS OR TRADE
SECRETS, (B) PHARMACEUTICAL, CHEMICAL AND BIOLOGICAL MATERIALS, PRODUCTS AND
COMPOSITIONS, (C) TESTS, ASSAYS, TECHNIQUES, DATA, METHODS, PROCEDURES,
FORMULAS, OR PROCESSES, (D) TECHNICAL, MEDICAL, CLINICAL, TOXICOLOGICAL, AND
OTHER SCIENTIFIC DATA AND OTHER INFORMATION RELATING TO ANY OF THE FOREGOING,
AND (E) DRAWINGS, PLANS, DESIGNS, DIAGRAMS, SKETCHES, SPECIFICATIONS, OR OTHER
DOCUMENTS CONTAINING OR RELATING TO SUCH INFORMATION OR MATERIALS.
1.41.
"LAW" OR "LAWS" MEANS ALL LAWS, STATUTES, RULES, REGULATIONS,
ORDERS, JUDGMENTS, OR ORDINANCES HAVING THE EFFECT OF LAW OF ANY FEDERAL,
NATIONAL, MULTINATIONAL, STATE, PROVINCIAL, COUNTY, CITY OR OTHER POLITICAL
SUBDIVISION.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.
6
1.42.
"LICENSED COMPOUND" MEANS [***].
FOR FURTHER CLARITY, IF ROCHE
TERMINATES A LICENSED COMPOUND IN ONE OR MORE REGIONS PURSUANT TO SECTION 12.3,
SUCH LICENSED COMPOUND SHALL CONTINUE TO BE DEEMED A LICENSED COMPOUND EXCEPT AS
PROVIDED IN ARTICLE XII UNLESS AND UNTIL ROCHE TERMINATES SUCH LICENSED COMPOUND
IN ALL REGIONS PURSUANT TO SECTION 12.3 (WHETHER ROCHE SO TERMINATES SUCH
LICENSED COMPOUND IN ALL REGIONS SIMULTANEOUSLY OR TERMINATES SUCH LICENSED
COMPOUND IN ALL REGIONS OVER TIME).
FOR THE SAKE OF CLARITY, ANY LICENSED
COMPOUND SHALL ALSO INCLUDE ALL PRO-DRUGS, METABOLITES, CONSTITUTIONAL AND
GEOMETRIC ISOMERS, REGIOISOMERS, STEREOISOMERS INCLUDING ENANTIOMERS AND
DIASTEREOISOMERS,